115 Case Processing Jobs - Page 4

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 47 b) To Apply for above Job Role ( Pune ) Type : Job Code # 48 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 51

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Review and verify the accuracy of medical documentation, including patient records, case reports, and clinical study reports. Ensure documentation complies with regulatory requirements and company standards. Regulatory Compliance: Stay updated with the latest regulatory guidelines and ensure all reviews align with current regulations. Prepare and review regulatory submissions to ensure timely and successful product approvals. Training and Development: Stay informed about advancements in medical research and regulatory changes. Participate in continuous training and development programs to enhance knowledge and skills. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 48 b) To Apply for above Job Role ( Chennai ) Type : Job Code # 52 c) To Apply for above Job Role ( Indore ) Type : Job Code # 53

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Ensure compliance with global and local procedural documents and local implementation of client Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Nagpur ) Type : Job Code # 49 b) To Apply for above Job Role ( Gandhinagar ) Type : Job Code # 50 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 51

Alcon Laboratories (India) Pvt. Ltd is looking for Associate I Safety Data Analyst to join our dynamic team and embark on a rewarding career journey. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Jubilant Organosys is looking for Executive - Pharmacovigilance to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety ScientistDrug Safety Scientist Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Position Purpose Conducts and manages Aggregate Safety Report QC activities (PADER, PSUR, DSUR etc) produced by the Aggregate Report Center of Excellence (CoE) to ensure accuracy, internal consistency, uniformity and compliance with global aggregate reporting commitments. Primary Responsibilities Support the Aggregate Report CoE by participating in and/or leading peer QC activities, set the standard for enhanced collaboration, and deliver project commitments. Plans, designs and participate independently, as appropriate, in the ongoing review and QC of a designated report s safety information. Participates on project teams, task forces and/or working groups to identify opportunities for peer QC process improvement initiatives. Manages special projects and senior management requests associated with peer QC compliance, as needed. Serve as a Peer QC Subject Matter Expert (SME) on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate. Collection of peer QC metric data for analysis. Support regulatory inspections, internal audits and/or strategic quality initiatives. Technical Skill Requirements Strategic Thinking with demonstrated ability to understand and consider competitive positioning when solving problems and making decisions. Demonstrated knowledge of safety, clinical and/or regulatory. Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies. Demonstrated ability to manage complex projects and cross-functional processes and to meet established deadlines. Demonstrated ability to effectively work on simultaneous complex projects/deliverables. Demonstrated analytical and statistical skills. Thorough understanding of system technologies that support the business. Can apply technical and line knowledge of key concepts and may act as a resource. Qualifications (i. e. , preferred education, experience, attributes) Education: BS degree (or equivalent). A scientific or technical degree is preferred. Experience: Prefers > 2 years experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry. Experience with aggregate reports like PADER or PSUR, case processing (ICSR), or other relevant experience. Experience in quality control and/or quality assurance within the pharmaceutical industry preferred. Knowledge of global safety regulations and guidelines, or equivalent. Demonstrated computer literacy, particularly in the use and management of relational databases. Demonstrated strength in analytical skills and attention to detail. Demonstrated organizational/project management skills. Demonstrated strength in oral/written communication and interpersonal skills. Ability to make decisions independently and resolve issues appropriately. Innovative and strategic thinking Work Location Assignment: Hybrid Work Location Assignment: Hybrid Quality Assurance and Control #LI-PFE

Should have Strong Knowledge in medical review of ICSRs and Pharmacovigilance Knowledge of safety databases, such as Argus, ARISg. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Required Candidate profile Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. BDS and MBBS Are eligible to apply

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

The Operations Support Specialist will work to support both Customer Success and Operations for the Investigative Research business unit. This includes answering customer inquiries via a white glove approach, review/comparison of received information and subsequently advising customers of missing information, answering team questions regarding case processing and systems/case updates. The candidate filling this role will require customer service and problem-solving skills, as well as be organized, responsive, and proactive in bringing forth recommendations for improvement. Roles and responsibilities will include: Coordinate aspect of vendor accounts (usernames, access issues), subcontractor relationships, assist with vendor logistics for teams, monitor onboarding/offboarding and invoice approval/billing issues tied to Investigative Research operations Monitor and respond to Chatter messages requesting missing information (to include customer outreach), review/comparison of received documents, and any other questions about a case in progress, as well as case initiation questions. Support Customer Success by monitoring the IR inbox to answer customer emails in a timely manner. This includes responding to price quotes, status requests, report questions, scoping order requests, etc. As needed, or as time allows, assist with case initiation, float among operations teams to assist in case processing, and update customer account information when outdated information is found. Educational Qualification and experience required for this role: Bachelor s degree or equivalent experience is required and preferred if investigative research related. Experience: 3+ years of experience in customer service/account management, including direct interactions with external customers 2+ years of experience in investigative research or a related role Other Knowledge, Skills, Abilities or Certifications: Proficient in Salesforce and Microsoft Outlook Teams. Exceptional professional written verbal (customer phone calls may be required at times) communication skills. Detail-oriented and well-organized. Ability to provide insight into areas that can improve. Able to work under limited guidance, and supervision. Able to keep personal information confidential. Work Location: Bangalore (Work from office)

Job Summary The Team Manager-CDM/PV role is crucial in overseeing the Pharma Research & Development processes within our organization. With a hybrid work model and rotational shifts the candidate will manage and optimize case processing and research activities. This position requires a minimum of 5 years of experience focusing on enhancing productivity and ensuring compliance with industry standards. Responsibilities Manage and oversee the Pharma Research & Development processes to ensure efficient workflow and compliance with industry standards. Coordinate with cross-functional teams to optimize case processing and research activities enhancing overall productivity. Implement strategies to improve data management and pharmacovigilance processes ensuring high-quality outcomes. Monitor and evaluate project progress providing insights and recommendations for continuous improvement. Facilitate communication between departments to ensure seamless integration of research and development activities. Develop and maintain documentation related to case processing and research ensuring accuracy and accessibility. Provide training and support to team members fostering a collaborative and productive work environment. Analyze data to identify trends and opportunities for process optimization and innovation. Collaborate with stakeholders to align project objectives with organizational goals and industry regulations. Ensure adherence to regulatory requirements and guidelines in all research and development activities. Utilize technical skills to troubleshoot and resolve issues related to data management and case processing. Drive initiatives to enhance the efficiency and effectiveness of pharmacovigilance operations. Support the development and implementation of new technologies and methodologies in research and development. Qualifications Possess a strong background in Pharma Research & Development with at least 5 years of relevant experience. Demonstrate expertise in PV Case Processing and Research and Development showcasing domain skills. Exhibit proficiency in data management and pharmacovigilance processes ensuring high-quality outcomes. Display excellent communication and coordination skills to facilitate cross-functional collaboration. Show ability to analyze data and provide actionable insights for process improvement. Hold experience in managing documentation and ensuring compliance with industry standards. Have a proactive approach to problem-solving and process optimization.

DesignationService Executive - Solar EPC Business Primary Responsibilities: We are looking for a Service Executive in our solar EPC business. You will be a key member of our operations team, responsible for ensuring the efficient operation and maintenance of solar energy systems installed by our company. You will work closely with customers, technicians, and other stakeholders to deliver exceptional service and support. Reporting toEngineering Head Requirement 1.Strong technical knowledge of solar PV systems and components. 2.Excellent problem-solving skills and attention to detail. 3.Good communication and interpersonal skills. 4.Ability to work independently and prioritize tasks effectively. 5.Willingness to travel to project sites as needed. Key Result Areas: Internal: - Technical Support - Data analysis and Reporting - Process Improvement - Training & Development - Quality Assurance - Cross Functional collaboration External: - Customer Satisfaction - Service Delivery - System Performance (PR) Monitoring - Relationship Management - Regulatory compliance - Customer Feedback Management About The Role : - Perform routine inspections and maintenance tasks on solar PV systems to ensure optimal performance and longevity. - Diagnose and troubleshoot technical issues, including but not limited to inverter failures, wiring problems, and module degradation. - Coordinate with field technicians and subcontractors to schedule service visits and repairs in a timely manner. - Monitor system performance using monitoring software and tools and take proactive measures to address any deviations from expected output. - Maintain accurate records of service activities, including site visit reports, maintenance logs, and customer communication. - Provide technical support to customers over the phone, via email, or on-site, answering questions and guiding them through troubleshooting steps.

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req Bachelors degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Intermediate

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. JLPT N3 certification is mandatory Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications Bachelors degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Intermediate

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent thats bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Responsibilities: Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs Processing literature, spontaneous as well as clinical trial and solicited cases Schedule and perform search of literature reports for valid ICSR in PubMed and MLM Responsible for generation of reports and submission to health authority and business partners Ensure data entry of serious and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy Responsible for coding events, indications and patient history based on MEDDRA Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events Responsible to obtain follow-up information for all serious and non-serious cases as per the guideline on Good Pharmacovigilance Practices (EU-GVP). Perform the submission of the processed cases to regulatory authority and report distribution to Partner. Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines Track and perform daily and monthly reconciliation of ICSRs as per client requirements EDUCATION: M.Pharm/Pharm D/Life sciences degree EXPERIENCE: A minimum of 1 year pharmacovigilance case processing experience or its equivalent. EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years Language - Ability: Japanese - Elementary What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Collaboration and interpersonal skills Commitment to quality Ability to perform under pressure Prioritization of workload Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Any Graduation

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English - Advanced What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Team lead experience Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BCom

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to establish strong client relationship Ability to work well in a team Collaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. MICC experience and ready to work in any shiftIn this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. MICC experience and ready to work in any shift What are we looking for? Adaptable and flexible Ability to perform under pressure Written and verbal communicationMICC experience and ready to work in any shift Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Master of Pharmacy

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom Years of Experience: 1 to 3 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Analyst Qualifications: BCom Years of Experience: 3 to 5 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Project Role : Program/Project Management Lead Project Role Description : Manage overall delivery of a program or project to achieve business outcomes. Define project scope and monitor execution of deliverables. Communicate across multiple stakeholders to manage expectations, issues and outcomes. Must have skills : Pharmacovigilance & Drug Safety Surveillance Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Program/Project Management Lead, you will oversee the delivery of programs or projects to achieve business objectives. You will define project scope, monitor execution, and communicate with stakeholders to manage expectations and outcomes effectively. Roles & Responsibilities: Involve monitoring and assessing the risks and benefits of medicines to patients, so it's vital for anyone working in this profession that the information they work on is accurate. Candidates will need to be thorough and precise in their work, paying attention to detail, as jobs in the pharmacovigilance sector require a responsible attitude. Incorrect information can have serious health and safety consequences. Expected to be an SME, collaborate and manage the team to perform. Responsible for team decisions. Engage with multiple teams and contribute on key decisions. Expected to provide solutions to problems that apply across multiple teams. Lead project planning and execution. Ensure project scope and objectives are clearly defined. Monitor project progress and address any issues. Communicate effectively with stakeholders to manage expectations. Professional & Technical Skills: -Observational skills as well as attention to detail-Analytical and problem-solving skills-Excellent communication skills, both written and verbalIT skills-Team working skills-Mathematical skills Project management and planning skills Ability to work in a fast-paced environment Additional Information: The candidate should have a minimum of 12 years of experience in Pharmacovigilance & Drug Safety Surveillance. This position is based at our Bengaluru office. A 15 years full time education is required. Qualifications 15 years full time education

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

At Allstate, great things happen when our people work together to protect families and their belongings from lifes uncertainties. And for more than 90 years our innovative drive has kept us a step ahead of our customers evolving needs. From advocating for seat belts, air bags and graduated driving laws, to being an industry leader in pricing sophistication, telematics, and, more recently, device and identity protection. About The Role The Application Developer Lead Consultant provides code/design analysis and strategy, supports project planning, and develops code and designs for complex projects. They manage the review of code, design, and testing for lower band Application Developers and peers. They serve as a technical expert, coach and mentor for other application developer specialists and professionals. The Lead Consultant works closely with business partners to identify needs and design technology solutions toovercome process bottlenecks, reduce use of contingent claim resources, reduce compliance risks, or generally increase operational efficiency. They are often required to deliver tactical solutions that can be implemented within a few days. They are responsible for all phases of the application development cyclebeginning with requirements gathering, through release, and ultimately ongoing user support. Key Responsibilities Should have strong JAVA, spring boot, triage, TDD and test understanding. "¢ Assists with detailed project estimating and milestone planning. Reviews and validate accuracy of others estimates and works with project managers in continuous process improvement for estimating "¢ Develops code for complex to highly complex modules with high-level architecture, following documentation and development standards "¢ Ensures that design/code reviews are scheduled and executed; provide feedback and recommends solutions; ensures that design standards and documentation are followed and certifies that code meets quality standards; reviews and critiques code presented by team members. "¢ Critiques and evaluates detailed business, functional, and high-level technical requirements (including recovery, security and audit) "¢ Performs root cause analysis to prevent recurrence of problem and manages the resolution of complex problems "¢ Defines and manages process by which support and technical assistance is performed "¢ Leads and organizes testing reviews. Tracks and resolves complex defects and assists in planning efforts of complex functional tests in support of Quality Control (QC) "¢ Ensures project change management approach is followed and that enhancements are appropriately prioritized and developed, and delivered to Developers, Quality Control Analysts, and Environment Management personnel, and that all documentation is completed appropriately. "¢ Contributes to determining programming approach, tools, and techniques that best meet the business requirements. Promotes and defines development standards and high architectural standards. Education "¢ 4 year Bachelors Degree (Preferred) Experience "¢ 5 or more years of experience (Preferred) Supervisory Responsibilities "¢ This job does not have supervisory duties. Education & Experience (in lieu) "¢ In lieu of the above education requirements, an equivalent combination of education and experience may be considered. Primary Skills Application Development, Code Reviews, Process Improvements, Technical Consulting, Technical Requirements Shift Time Shift B (India) Recruiter Info Shriya Kumari skuow@allstate.com About Allstate Joining our team isnt just a job "” its an opportunity. One that takes your skills and pushes them to the next level. One that encourages you to challenge the status quo. And one where you can impact the future for the greater good. Youll do all this in a flexible environment that embraces connection and belonging. And with the recognition of several inclusivity and diversity awards, weve proven that Allstate empowers everyone to lead, drive change and give back where they work and live. Good Hands. Greater Together. The Allstate Corporation is one of the largest publicly held insurance providers in the United States. Ranked No. 84 in the 2023 Fortune 500 list of the largest United States corporations by total revenue, The Allstate Corporation owns and operates 18 companies in the United States, Canada, Northern Ireland, and India. Allstate India Private Limited, also known as Allstate India, is a subsidiary of The Allstate Corporation. The India talent center was set up in 2012 and operates under the corporations Good Hands promise. As it innovates operations and technology, Allstate India has evolved beyond its technology functions to be the critical strategic business services arm of the corporation. With offices in Bengaluru and Pune, the company offers expertise to the parent organizations business areas including technology and innovation, accounting and imaging services, policy administration, transformation solution design and support services, transformation of property liability service design, global operations and integration, and training and transition. Learn more about Allstate India here.