Job Overview Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Assume accountability of quality of the deliverables and implementation of quality processes with minimal support from the Manager. Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices, and conventions on the assigned projects. Act as the process and quality expert for the Client. Work with other team members to analyze Quality findings and help develop action plans. Ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Provide adequate oversight to ongoing sample case reviews and perform reviews as required. Publish quality metrics based on this review and use it to ensure deliverables meet agreed quality targets. Identify, report quality trends to internal and external stakeholders, suggest corrective actions and monitor the execution and closure. Assume ownership of quality of reports and CAPAs as assigned. Ensure that CAPAs are implemented for the assigned project. Conduct process review in coordination with Project Manager and Quality Manager to identify process gaps and proactively coordinate with the delivery team to develop process standards and suggest process improvements. Measure and track audit readiness for assigned projects. Lead authoring, reviews, training and distribution of SOPs, project specific Work Instructions / convention documents etc. Work with individuals in identifying training needs based on quality review findings. Assist in designing sign-off criteria, development and tracking of training schedule and training material for new hires and existing team. Ensure that periodic feedback is provided to the team based on review findings. Initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. Communicate with internal Subject Matter experts to get clarification on case-processing queries and providing feedback to team. Responsible to coordinate and handle queries during the client or external audits of the assigned projects. Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests. Responsible for developing Quality Management Plan and / or contributing to the Quality Agreement for assigned projects. Support Computer System Validation related activities as required. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes - a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Five years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least Two years’ experience in Peer review/Quality review. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Knowledge of Quality Assurance. Awareness of lean methodology concepts. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred. Physical Demands/Work Environment Office Environment . Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Assume accountability of quality of the deliverables and implementation of quality processes with minimal support from the Manager. Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices, and conventions on the assigned projects. Act as the process and quality expert for the Client. Work with other team members to analyze Quality findings and help develop action plans. Ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Provide adequate oversight to ongoing sample case reviews and perform reviews as required. Publish quality metrics based on this review and use it to ensure deliverables meet agreed quality targets. Identify, report quality trends to internal and external stakeholders, suggest corrective actions and monitor the execution and closure. Assume ownership of quality of reports and CAPAs as assigned. Ensure that CAPAs are implemented for the assigned project. Conduct process review in coordination with Project Manager and Quality Manager to identify process gaps and proactively coordinate with the delivery team to develop process standards and suggest process improvements. Measure and track audit readiness for assigned projects. Lead authoring, reviews, training and distribution of SOPs, project specific Work Instructions / convention documents etc. Work with individuals in identifying training needs based on quality review findings. Assist in designing sign-off criteria, development and tracking of training schedule and training material for new hires and existing team. Ensure that periodic feedback is provided to the team based on review findings. Initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. Communicate with internal Subject Matter experts to get clarification on case-processing queries and providing feedback to team. Responsible to coordinate and handle queries during the client or external audits of the assigned projects. Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests. Responsible for developing Quality Management Plan and / or contributing to the Quality Agreement for assigned projects. Support Computer System Validation related activities as required. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes - a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Five years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least Two years’ experience in Peer review/Quality review. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Knowledge of Quality Assurance. Awareness of lean methodology concepts. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred. Physical Demands/Work Environment Office Environment . Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform Quality review of assigned cases. Assist in compiling quality metrics based on this review and identifying quality trends. Assist in addressing periodic client quality reviews. Assist in preparation of Corrective and preventive actions as requested. Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Assist in the conduct of process review for assigned process and measure and monitor audit readiness. Assist in designing and tracking training schedule and training material for new hires and existing team. Contribute to discussion forums on Quality errors within assigned project and help identify process improvements. Assist in coordinating respective client or external audits of the assigned projects as requested. Assist in development of Quality Management Plan for assigned project. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Contribute to process review and use results to identify the process improvement initiatives. Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable. Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor. Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Two plus years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with some experience in Peer review/Quality review. Ability to present and share useful business information across departments and functions. Ability to anticipate and identify problems and take appropriate action to correct. Knowledge of medical and drug terminology. Knowledge of Good Clinical Practice (GCP) and GVP requirements related to clinical safety and post marketing documentation. Knowledge of ICH Guidelines. Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Knowledge of Medical Device reporting desirable. Physical Demands/Work Environment Office Environment Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview The Director of Product Engineering will lead the strategy and development of our Patient Safety software. This role is pivotal in shaping innovative solutions that meet the evolving needs of our clients in the life science sector. The successful candidate will bridge the gap between technology and business, ensuring our products not only excel in functionality but also in market relevance and user satisfaction. Success in this role means delivering products that are at the forefront of industry standards, driving user engagement, and achieving strategic business goals. Summary Of Responsibilities Lead the product life cycle from conception to launch, aligning product vision with customer needs and business goals. Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector. Define and prioritize product requirements, features, and functionalities in collaboration with engineering, sales, and customer support teams. Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders. Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success. Foster strong relationships with key clients and industry experts to gather insights and feedback for continuous product improvement. Ensure compliance with industry regulations and standards. Manages product like a business owner, owning portfolio forecasts, budget management, and driving efficiency into teams and utilization of resourcing including consumption of licenses and 3rd party spend. Manage support teams responsible for the Patient Safety incident and problem management processes. Manage all other duties as needed or assigned, ensuring flexibility and adaptability to changing business needs. Qualifications (Minimum Required) Bachelor’s degree in computer engineering Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Proficiency in product management tools and methodologies (including DevOps) Exceptional analytical, strategic thinking, and problem-solving skills. Excellent communication and interpersonal skills, capable of working effectively with cross functional teams. Experience (Minimum Required) At least 6+ years of experience in product management within the life sciences or software development industry in Pharmacovigilance. Experience in developing and launching software products Proven track record of managing all aspects of a successful product throughout its lifecycle. Experience with Agile Methodologies. Experience with managing globally diverse matrixed teams. Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships.). Knowledge of Gxp and highly regulated environments. Drive innovation and continuous improvement in patient safety solutions with knowledge of industry technology and product trends in the Patient Safety space Focusing on user centered design principles for an intuitive product Understanding of data Preferred Qualifications/Experience Include Advanced degree (MBA or equivalent) in Business, Life Sciences, or related field. Prior experience in a startup or a fast-paced environment. Certification in Product Management or Agile methodologies. Strong understanding of Patient Safety processes within the CRO industry. Strong technical background with understanding of software development processes. Demonstrated ability to think creatively and strategically when solving problems and making decisions. Learn more about our EEO & Accommodations request here. Show more Show less

Summary Of Responsibilities Respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned – tracking several types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Create and revise training materials based on procedural, system, and regulation updates. Responsible in conducting trainings and checks the effectiveness of the trainings as required. Assume responsibility for quality of data processed. Any other duties as assigned by management. And all other duties as needed or assigned. Qualifications (Minimum Required) Bachelor’s or Masters in Pharmacy or Life Science or Medical Science or related area + 2 to 3 years of safety experience. BS/BA + 2 to 3 years of safety experience. MA/MS/PharmD + 1 to 2 years of safety experience. Associate degree + 4-5 years relevant experience** (or 2+ years safety experience) * Non degree + 5-6 years relevant experience** (or 2+ years safety experience) * Fortrea may consider relevant and equivalent experience in lieu of educational requirements. *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance. Fluent in English, both written and verbal. Experience (Minimum Required) Experience in call center operations is preferred Preferred Qualifications Include Degree preferred (but not necessarily) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry. Good written and verbal communication skills. Ability to receive and manage in-bound and out-bound calls. Ability to analyze and synthesize medical information. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines. Technical proficiency with Microsoft Office suite applications. High degree of accuracy with attention to detail. Functions as a team player. Ability to work independently with moderate supervision. Learn more about our EEO & Accommodations request here. Show more Show less

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. Performs aggregate and signal analysis activities, as required in support of single case processing. Creates, maintains, and assumes accountability for a culture of high customer service. Qualifications (Minimum Required) Bachelor’s degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher. Experience (Minimum Required) Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. Knowledge and understanding of regulatory requirements for Clinical Research. Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment Office or home-based environment, as requested by the line manager. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea Is Proud To Be An Equal Opportunity Employer As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application. Show more Show less

Job Overview It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform Quality review of assigned cases. Assist in compiling quality metrics based on this review and identifying quality trends. Assist in addressing periodic client quality reviews. Assist in preparation of Corrective and preventive actions as requested. Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Assist in the conduct of process review for assigned process and measure and monitor audit readiness. Assist in designing and tracking training schedule and training material for new hires and existing team. Contribute to discussion forums on Quality errors within assigned project and help identify process improvements. Assist in coordinating respective client or external audits of the assigned projects as requested. Assist in development of Quality Management Plan for assigned project. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Contribute to process review and use results to identify the process improvement initiatives. Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable. Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor. Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Two plus years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with some experience in Peer review/Quality review. Ability to present and share useful business information across departments and functions. Ability to anticipate and identify problems and take appropriate action to correct. Knowledge of medical and drug terminology. Knowledge of Good Clinical Practice (GCP) and GVP requirements related to clinical safety and post marketing documentation. Knowledge of ICH Guidelines. Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Knowledge of Medical Device reporting desirable. Physical Demands/Work Environment Office Environment Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview The Director of Product Engineering will lead the strategy and development of our Patient Safety software. This role is pivotal in shaping innovative solutions that meet the evolving needs of our clients in the life science sector. The successful candidate will bridge the gap between technology and business, ensuring our products not only excel in functionality but also in market relevance and user satisfaction. Success in this role means delivering products that are at the forefront of industry standards, driving user engagement, and achieving strategic business goals. Summary Of Responsibilities Lead the product life cycle from conception to launch, aligning product vision with customer needs and business goals. Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector. Define and prioritize product requirements, features, and functionalities in collaboration with engineering, sales, and customer support teams. Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders. Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success. Foster strong relationships with key clients and industry experts to gather insights and feedback for continuous product improvement. Ensure compliance with industry regulations and standards. Manages product like a business owner, owning portfolio forecasts, budget management, and driving efficiency into teams and utilization of resourcing including consumption of licenses and 3rd party spend. Manage support teams responsible for the Patient Safety incident and problem management processes. Manage all other duties as needed or assigned, ensuring flexibility and adaptability to changing business needs. Qualifications (Minimum Required) Bachelor’s degree in computer engineering Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Proficiency in product management tools and methodologies (including DevOps) Exceptional analytical, strategic thinking, and problem-solving skills. Excellent communication and interpersonal skills, capable of working effectively with cross functional teams. Experience (Minimum Required) At least 6+ years of experience in product management within the life sciences or software development industry in Pharmacovigilance. Experience in developing and launching software products Proven track record of managing all aspects of a successful product throughout its lifecycle. Experience with Agile Methodologies. Experience with managing globally diverse matrixed teams. Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships.). Knowledge of Gxp and highly regulated environments. Drive innovation and continuous improvement in patient safety solutions with knowledge of industry technology and product trends in the Patient Safety space Focusing on user centered design principles for an intuitive product Understanding of data Preferred Qualifications/Experience Include Advanced degree (MBA or equivalent) in Business, Life Sciences, or related field. Prior experience in a startup or a fast-paced environment. Certification in Product Management or Agile methodologies. Strong understanding of Patient Safety processes within the CRO industry. Strong technical background with understanding of software development processes. Demonstrated ability to think creatively and strategically when solving problems and making decisions. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Corporate Counsel Client Contracts provides legal support and counseling for Fortrea and their business leaders for matters relating to client agreements and performance thereof. As the Corporate Counsel, you will be responsible for providing advice and counsel on a wide variety of client contracting and relationship issues for our global operations. The role is primarily focused on supporting contracts management, business units and operations, and initiatives within the corporate functions and departments. This role works closely with the Senior Counsel- Client Contracts to provide day-to-day advice and subject matter expertise across the full range of client contracting matters, operational performance and matters impacting the global business. Summary Of Responsibilities Provide advice and support to Company departments on client issues in a commercially reasonable manner that protects the company’s fundamental interests and in a manner consistent with company rules, practices, and policies. Collaborate with other department staff to provide advice and support that accurately reflect the company’s obligations or rights and understandings with clients. Provide advice and support for the drafting, negotiation, and review of company contracts by commercial contracts team and other members of the department’s staff. Participate in negotiations with clients and their counsel as required. Provide advice and counsel to the business and other stakeholders regarding client disputes, performance issues, quality events and other client-related matters that may pose legal risk to the company. Suggest improvements to company contractual templates on an ongoing basis in response to emerging trends, customer preferences, and the company’s risk management posture. Lead or support dispute resolution and claims management Recommend improvements and implement systems to ensure the prompt and effective processing of requests for support. Promote adoption of company-wide risk management initiatives, contracting policies, and other corporate goals as directed. Implement strategies and policies that minimize risk exposure, including (but not limited to): preventive legal training, timely and accurate advice to company operational staff, and careful review of company contracts or other obligations in a manner consistent with guidance provided. Provide legal support for confidentiality disclosures and client disputes Conduct legal review of marketing and communications materials Fulfill other duties as required by the Department and the Company. Qualifications (Minimum Required) Education level: Juris Doctor degree or equivalent Ability to maintain confidentiality of information during interactions with staff at all levels Excellent contract drafting and negotiation skills Experience reviewing commercial contracts and providing practical, business-focused advice Comprehensive knowledge of general corporate business practices and a sound understanding of contracting models and commercial practices is required. Ability to counsel, interact with and present to mid-level and senior executives. Proficient with MS Office products Excellent written and verbal communications skills. Excellent drafting and legal interpretation skills. Sound analytical skills to review matters and identify key legal issues. Effective time management and organizations skills. Must be pro-active, be able to work independently and possess the initiative to drive projects and matters forward to resolution. Dedication to fostering an inclusive culture and value diverse perspectives. Experience (Minimum Required) 8+ years of experience with a reputed law firm or as an in-house lawyer. Industry experience or knowledge of clinical development strongly preferred Preferred Qualifications Include MS Office, Teams, Workday, Sharepoint Physical Demands / Work Environment Remote role Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and costeffective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems. Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines. Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines. Assist in the reconciliation of databases, as applicable. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable. Support upload/archival of case/study/project documentation, as appropriate. Build and maintain good PSS relationships across functional units. Support compliance of operations with governing regulatory requirements. All other duties as needed or assigned. Qualifications (Minimum Required) Healthcare professionals with 0 to 6 months relevant experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area *Safety experience includes actual experience of processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Experience (Minimum Required) Attention to detail. Team player. Solid written and verbal communication skills. Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data. Knowledge of MS office Windows applications beneficial. Ability to operate standard office equipment. Physical Demands/Work Environment Office Environment. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Process the adverse event reports from any source as per client/sponsor agreed plans. Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems; Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA, if applicable to Determine lists against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed. Ensure case receives appropriate medical review. Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines. Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to- o Maintenance of tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, as required, within study specified timelines. Support with quality review or peer review of the processed reports. Assist and/or complete the database reconciliation and the associated activities, as applicable. Maintain study/project level documentation as per the agreed requirements, as applicable. Support with training of PSS staff and mentor the team as needed. Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed). Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting, and pharmacovigilance. Assist in the preparation for client meetings and liaise with client contacts, where appropriate. Assist in Quality issues management and support audit and inspection preparation, as needed. Ensure compliance of operations with governing regulatory requirements and applicable study/project plans and take responsibility for quality of data processed. Assist in the preparation of client meetings and liaise with clients where appropriate ¨ Any other duties as assigned by management. The above job duties are completed by the staff as applicable, depending on the role they are assigned to. Qualifications (Minimum Required) Non-degree + 1 year of Safety experience or 3 years relevant experience. Associate degree + 1 year of Safety experience or 2 years relevant experience. BS/BA + 1 year of relevant experience. MS/MA + 1 year of relevant experience. PharmD + 1 year of relevant experience. For PharmD, a one-year residency of fellowship can be considered as relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. Experience (Minimum Required) High degree of accuracy with attention to detail. Functions as a team player and offer peer support as needed. Good written and verbal communication skills. Ability to work independently with moderate supervision. Good keyboard skills with knowledge of MS Office and Windows application would be beneficial ¨ Mentoring skills preferred. Preferred Qualifications Include Office Environment or remote. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of Responsibilities: Process the adverse event reports from any source as per client/sponsor agreed plans. Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems; Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA, if applicable to Determine lists against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed. Ensure case receives appropriate medical review. Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines. Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to- o Maintenance of tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, as required, within study specified timelines. Support with quality review or peer review of the processed reports. Assist and/or complete the database reconciliation and the associated activities, as applicable. Maintain study/project level documentation as per the agreed requirements, as applicable. Support with training of PSS staff and mentor the team as needed. Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed). Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting, and pharmacovigilance. Assist in the preparation for client meetings and liaise with client contacts, where appropriate. Assist in Quality issues management and support audit and inspection preparation, as needed. Ensure compliance of operations with governing regulatory requirements and applicable study/project plans and take responsibility for quality of data processed. Assist in the preparation of client meetings and liaise with clients where appropriate ¨ Any other duties as assigned by management. The above job duties are completed by the staff as applicable, depending on the role they are assigned to. Qualifications (Minimum Required): Non-degree + 1 year of Safety experience or 3 years relevant experience. Associate degree + 1 year of Safety experience or 2 years relevant experience. BS/BA + 1 year of relevant experience. MS/MA + 1 year of relevant experience. PharmD + 1 year of relevant experience. For PharmD, a one-year residency of fellowship can be considered as relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. Experience (Minimum Required): High degree of accuracy with attention to detail. Functions as a team player and offer peer support as needed. Good written and verbal communication skills. Ability to work independently with moderate supervision. Good keyboard skills with knowledge of MS Office and Windows application would be beneficial ¨ Mentoring skills preferred. Preferred Qualifications Include: Office Environment or remote. Learn more about our EEO & Accommodations request here.

Job Overview: Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary of Responsibilities: Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. Performs aggregate and signal analysis activities, as required in support of single case processing. Creates, maintains, and assumes accountability for a culture of high customer service. Qualifications (Minimum Required): Bachelor’s degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher. Experience (Minimum Required): Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. Knowledge and understanding of regulatory requirements for Clinical Research. Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include: 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment: Office or home-based environment, as requested by the line manager. Learn more about our EEO & Accommodations request here.

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and costeffective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems. Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines. Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines. Assist in the reconciliation of databases, as applicable. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable. Support upload/archival of case/study/project documentation, as appropriate. Build and maintain good PSS relationships across functional units. Support compliance of operations with governing regulatory requirements. All other duties as needed or assigned. Qualifications (Minimum Required) Non-Degree or 6 months - 1 year of Safety experience* or relevant experience ** Associate Degree with 0-6 months of Safety experience* or relevant experience** BS/BA with 0- 6 months of Safety experience* or relevant experience** MS/MA with 0 yrs. of Safety experience* or relevant experience** PharmD with 0 yrs. of Safety experience* or relevant experience** Fortrea may consider relevant and equivalent experience in lieu of educational requirements. To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area *Safety experience includes actual experience of processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Experience (Minimum Required) Attention to detail. Team player. Solid written and verbal communication skills. Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data. Knowledge of MS office Windows applications beneficial. Ability to operate standard office equipment. Physical Demands/Work Environment Office Environment or remote. Learn more about our EEO & Accommodations request here.

Job Overview: Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include receiving and logging-in and scanning contractual and user administration documentation.Assist project teams with user management tasks, i.e., user access across platforms, supporting team on access related topics, update daily tracker. Provide necessary reports at required intervals and follow-up. Summary of Responsibilities: Ensures consistency and accuracy of understanding the User Admin Plans (UAPs). Updating necessary trackers. Participates in staff meetings as appropriate. Continuously learn and improve communication and technical skills. Maintains job aids and completes applicable user ad min checklists. Assist with the preparation of controlled documents prior to processing or imaging as requested. Execute validation test scripts as requested. Interact with project team members in related discipline e.g. Clinical Data Management, Clinical Operations and Data Management. Performs other duties as assigned by Manager or Supervisor or Senior staff. Display a positive attitude at all times, promoting and contributing to good team spirit in a professional environment. Attention to detail is essential and all tasks must be carried out to the highest standard. Carry out all activities according to Company Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines. Follow proper email and communication etiquette as required for the task Maintain accurate records of all work performed. Perform other duties as assigned by management. And all other duties as needed or assigned. Qualifications (Minimum Required): 0 - 1 years of relevant work experience to include user management support and execution. A neat, methodical and thorough approach to the work with an emphasis on attention to detail. Ill Good concentration skills are required to meet the consistently high standards expected. Experience (Minimum Required): Self-motivation with the ability to work under pressure to meet demanding deadlines. Effective communication skills and the ability to work as part of a team. Good analytical skills. Good problem-solving skills and a proactive approach. Flexibility - being able to move from one computer system to another with ease and adapt to new technology and a constantly changing work environment. Preferred Qualifications Include: University/ college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution. Fluent in English, both written and verbal. Learn more about our EEO & Accommodations request here.

Job Overview Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include receiving and logging-in and scanning contractual and user administration documentation.Assist project teams with user management tasks, i.e., user access across platforms, supporting team on access related topics, update daily tracker. Provide necessary reports at required intervals and follow-up. Summary Of Responsibilities Ensures consistency and accuracy of understanding the User Admin Plans (UAPs). Updating necessary trackers. Participates in staff meetings as appropriate. Continuously learn and improve communication and technical skills. Maintains job aids and completes applicable user ad min checklists. Assist with the preparation of controlled documents prior to processing or imaging as requested. Execute validation test scripts as requested. Interact with project team members in related discipline e.g. Clinical Data Management, Clinical Operations and Data Management. Performs other duties as assigned by Manager or Supervisor or Senior staff. Display a positive attitude at all times, promoting and contributing to good team spirit in a professional environment. Attention to detail is essential and all tasks must be carried out to the highest standard. Carry out all activities according to Company Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines. Follow proper email and communication etiquette as required for the task Maintain accurate records of all work performed. Perform other duties as assigned by management. And all other duties as needed or assigned. Qualifications (Minimum Required) 0 - 1 years of relevant work experience to include user management support and execution. A neat, methodical and thorough approach to the work with an emphasis on attention to detail. Ill Good concentration skills are required to meet the consistently high standards expected. Experience (Minimum Required) Self-motivation with the ability to work under pressure to meet demanding deadlines. Effective communication skills and the ability to work as part of a team. Good analytical skills. Good problem-solving skills and a proactive approach. Flexibility - being able to move from one computer system to another with ease and adapt to new technology and a constantly changing work environment. Preferred Qualifications Include University/ college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution. Fluent in English, both written and verbal. Learn more about our EEO & Accommodations request here.

Senior Corporate Counsel Employment Law provides employment legal support and counseling for Fortrea and their business leaders. As the APAC Senior Employment Counsel, you will be responsible for providing advice and counsel on a wide variety of employment law issues for operations located in India as well as Australia, China, Hong Kong, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, and other Asia Pacific operations. This role works closely with the VP Employment Law to provide day-to-day advice and subject matter expertise across the full range of employee relations and other labor and employment matters. Summary Of Responsibilities Providing legal advice and support to Human Resources department (HR) and other stakeholders in relation to a broad range of employee related issues, such as recruitment, background screening, benefits, employee conduct and terminations. Reviewing and drafting employment related documentation such as employment contracts, termination agreements, employee policies and training materials. Advising in relation to employee relations matters, including investigations, conduct issues and disciplinary matters. Providing legal advice with respect to potential litigation and legal risks, coordinating and managing litigation matters. Advising HR and other stakeholders, and as appropriate, engaging external counsel; thereafter, coordinating external counsel advice. Providing training to HR and other business areas as required Qualifications (Minimum Required) Education level: Juris Doctor degree or equivalent Sound knowledge of India employment law is essential, and experience with employment law oversight for jurisdictions located in Asia Pacific region is preferred. Experience in advising on complex employment related disputes and issues. Excellent written and verbal communications skills. Excellent drafting and legal interpretation skills. Sound analytical skills to review matters and identify key legal issues. Effective time management and organizations skills. Must be pro-active, be able to work independently and possess the initiative to drive projects and matters to resolution. Dedication to fostering an inclusive culture and value diverse perspectives. Experience (Minimum Required) Lawyer with 10+ years post qualification experience either with a reputed law firm or as an inhouse employment lawyer. Experience effectively liaising with outside counsel across jurisdictional time zones Industry experience or knowledge of clinical development strongly preferred Preferred Qualifications Include MS Office, Teams Physical Demands / Work Environment The position will be located in Bangalore; however, we offer flexible scheduling and remote working alternatives within the role’s jurisdiction. Learn more about our EEO & Accommodations request here.

Summary Of Responsibilities Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives, Code adverse events accurately using MedDRA. Determine listedness against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from the reports and ensures its collection; Prepare follow-up correspondence in consultation with the medical staff, as needed. Ensure case receives appropriate medical review. Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, 3rd party vendor, Partner and Fortrea project personnel, if required, within study specified timelines. Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Assist or contribute to Database reconciliation in liaison with Data Management team or clients. Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, includes but not limited to: Maintenance of adverse event tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines. Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed. Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Assist in the generation and maintenance of the PSS metrics. Support preparation for client meetings and liaise with clients where appropriate. Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable. Prepare and support coordination of safety study files for archiving at completion of projects. Support Root cause analysis and CAPA plan development for the identified quality issues, as needed. Support and/or participate in audits and inspections including the preparation, as needed. Demonstrate role-specific Core Competencies and company values on a consistent basis. Build and maintain good PSS relationships across functional units. All other duties as needed or assigned. Learn more about our EEO & Accommodations request here.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. Performs aggregate and signal analysis activities, as required in support of single case processing. Creates, maintains, and assumes accountability for a culture of high customer service. Qualifications (Minimum Required) Bachelor’s degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher. Experience (Minimum Required) Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. Knowledge and understanding of regulatory requirements for Clinical Research. Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment Office or home-based environment, as requested by the line manager. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea Is Proud To Be An Equal Opportunity Employer As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.

Summary Of Responsibilities Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned. Qualifications (Minimum Required) University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. Thorough knowledge of monitoring procedures. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND A minimum of 3 years of Clinical Monitoring & Oncology experience. Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines. Ability to work with minimal supervision. Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Good planning, organization, and problem-solving abilities. Works efficiently and effectively in a matrix environment. Preferred Qualifications Include Thorough working knowledge of Fortrea SOPs for site monitoring. One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. Phase I monitoring experience. Life Science or Nursing qualification. Specific skills, systems, certifications, and/or licenses preferred. Personal characteristics (leadership, problem solving, interpersonal skills). Good attention to detail. Methodical approach to work. Good understanding of medical and clinical research terminology and clinical research processes. An understanding of the basics of physiology, pharmacology, and medical devices (when applicable). Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications. Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English. Focus on Customer. Innovate and Change. Pursue Scientific and Process Excellence. Work with Others. Achieve Results. Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. Demonstrated ability to conduct clinical operations activities most effectively and efficiently. Good analytical and negotiation skills. Experience using e-clinical systems [e.g., clinical trial management system (CTMS)]. For medical device positions, experience in providing customer service to device end users. Physical Demands/Work Environment Must be able to sit at a computer for long periods of time. Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day. Standard office and/or home working environment. Clinical Research Unit and hospital environment (administrative only). Risk of eye strain. Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites). Learn more about our EEO & Accommodations request here.