115 Case Processing Jobs - Page 2

Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases. Data entry into PV database Initial ICSR assessment, if applicable Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines Preparation of standard reporting forms (eg, CIOMS I / MedWatch Forms and XML files) Preparation and sending of follow up requests Submission of ICSRs to Health Authorities and partners of a client Case completion / documentation Conduct quality checks of Individual Case Safety Reports (ICSRs) and ensure quality assurance in accordance with project requirements, maintaining compliance with industry standards and best practices to enhance the integrity and reliability of safety data. The ICSR search/retrieval process from the EVWEB database and company/non-company assessment for cases. Allocation and cases workload management Providing training of the system to the respective team members. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements. The ICSR search/retrieval process from the EVWEB database and company/non-company assessment for cases. Allocation and cases workload management Providing training of the system to the respective team members. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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. 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 Affiliate Team AssociateAffiliate Team Associate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture 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. 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 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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. 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. 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 Qualification BSc,Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years Language - Ability: English(International) - Advanced About Accenture 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. Visit us at www.accenture.com What would you do 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.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.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. What are we looking for 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.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. 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 Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture 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. 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.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 relationshipAbility to work well in a teamCollaboration 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 Qualification Bachelor of Pharmacy

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture 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. Visit us at www.accenture.com 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 flexibleAbility to perform under pressureAgility for quick learningAbility to work well in a teamCommitment to quality 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 Qualification BCom,MCom,Master of Business Administration

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc. ) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc. ) Mentoring and training of new and more junior employees within the department, including procedure optimization and development

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Case report Medical review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience : Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education: MBBS/MD

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

Role & responsibilities Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level. Perform case follow up activities such as identification of information to be collected during follow-up. Creating and reviewing case narratives. Providing client notifications as required for case management. Case downloading from regulatory authority websites Submission to applicable regulatory authorities within stipulated timelines Supporting and contributing to the development of training materials and training delivery. Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs. Acquire and maintain an up-to-date knowledge of global safety regulations for medicines. Peer reviews of cases for quality, consistency, and accuracy as needed. Other duties as assigned Preferred candidate profile Strong verbal, written and interpersonal communication skills. High level of accuracy and attention to detail. Excellent organization and prioritization skills; able to multitask. Basic knowledge of Pharmacovigilance. Interested applicants can also apply directly with updated CV to hr@qpsbioserve.com

Title We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Determine plan of action for incoming calls; Collect, process, and track incoming adverse and serious adverse events; Write safety narratives; Report on various safety data; and Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes. Qualifications Bachelor's degree in Healthcare related field; Nursing, Pharmacy, Pharmacology, etc Clinical experience or Clinical Research, case processing and Post marketing Pharmacovigilance experience is preferred; Proficient English is required Proficient knowledge of Microsoft® Office; Broad knowledge of medical terminology; and Strong organizational and communication skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years About Accenture 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. 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 Junior Drug Safety AssociateJunior Drug Safety Associate 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 Qualification Bachelor of Physiotheraphy

At PrimeVigilance, Junior PV Officer/ PV Officers are experienced case processing team members who are expected to manage a variety of case processing and quality review activities with minimal guidance from senior team members. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. Reconciliation activities for all types of received reports Workflow management activities Requirements: Life science / bio medical background - healthcare related degree (chemistry, biology, biotechnology, veterinary science) Demonstrated full start to finish case processing experience and quality review exp

At PrimeVigilance, Junior PV Officer/ PV Officers are experienced case processing team members who are expected to manage a variety of case processing and quality review activities with minimal guidance from senior team members. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. Reconciliation activities for all types of received reports Workflow management activities

Job description Bangalore, India Job category Reg Affairs & Safety Pharmacovigilance Department Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate and chair the NN cross-functional safety committee throughout the lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities Act as Ownerof the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer. As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates. Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator s Brochure (IB), integrated safety summaries, abstracts and planned publications. You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required. Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs). Qualifications Masters in Medicine/MD post MBBS graduate is Preferred. Relevant Experience in Signal Management, Aggregate Management, ICSR. Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint). Fluent in written and spoken English. Analytical mind-set. Professional authority. Quality mind-set, well-organised and strive for excellence. Pro-active planner to meet agreed deliverables. Strong communicator (verbally and in writing). Curious and constantly looking for improvement opportunities. Team player with high degree of flexibility and service mindedness. Cross-cultural awareness. Ability and willingness to quickly adjust to changes in a continuously developing environment.

First link of management between the executors ie field staff and management. An effective communicator with exceptional relationship management skills with ability to relate to people at all levels of business and management. Delivery of business AOP objectives for the assigned geography. PRINCIPAL ACCOUNTABILITIES (Accountabilities associated with the job) Achieving business numbers with the assigned line of channels (Basis location and market potential). People Management (Off roll) - Hiring, Retention & Productivity. Sales Governance through compliance of systems and processes. Responsible for tracking, managing & controlling PDD requirement compliance Reduction in customer complaints & cancellation by ensuring that no miss-selling is being done. Understanding of CRM - Salesforce.com. Effectively engage with Credit, Operations, Risk & within 2W/3W teams. To ensure TAT is maintained for case processing. 4. MAJOR CHALLENGES (Challenges faced on an on-going basis in carrying out the job) Training of self and their team below. Hiring right candidate. Smooth onboarding to help settle the employee we'll in BFL. Smooth onboarding of New Dealer/Partner with BFL Retention of Off-roll staff 5. DECISIONS (Key decisions taken by job holder at his/her end) Hiring of Off roll staff Approvals by coordinating with internal stake holders eg. Clearing cases Lead allocation Field activity planning and closure 6. INTERACTIONS (Key working relationships a job holder needs to have INSIDE and OUTSIDE the company to accomplish the job) Internal Clients Roles you need to interact with inside the organization to enable success in your day to day work Connect with various internal department ie product, credit, Ops, RCS & compliance to process the file. Connect with HR department for hiring & retention External Clients Roles you need to interact with outside the organization to enable success in your day to day work Engaging with customer. Mapping of market competition. 7. DIMENSIONS (Key numerical data which will reflect the scope and scale of activities concerning this job) Financial Dimensions (These should be quantifiable numerical amounts) From 45 to 70 Cases MOM (depending upon location and market potential) Other Dimensions (Significant volume dimensions associated with the job) Total Team Size: 9 Number of Direct Reports: 5 to 9 Number of Indirect Reports: NA Number of Outsourced employees: 5 to 9 Number of locations: 1 to 4 Number of products: 1 ie Two wheeler Loan Required Qualifications and Experience SKILLS AND KNOWLEDGE (Minimum acceptable proficiency for this job which best indicates the education and/or experience requirements of this job and not the incumbent) Educational Qualifications Qualifications - Graduate / Post Graduate Good command in excel is essential. Work Experience - 1 to 3 years of relevant experience in managing team Result oriented - Go getter attitude is must Should have collaborative work style to engage with peers & colleagues across the company. Excellent Team management & Interpersonal Skills. Excellent command over communication skills. Highly ambitious & self-motivated

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing 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.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 work well in a team Adaptable and flexible Agility for quick learning 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,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 7 to 11 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? Agility for quick learning Adaptable and flexible Ability to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications MBBS

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 2 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.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 Ability to work well in a team Adaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS

First link of management between the executors ie field staff and management. An effective communicator with exceptional relationship management skills with ability to relate to people at all levels of business and management. Delivery of business AOP objectives for the assigned geography. PRINCIPAL ACCOUNTABILITIES (Accountabilities associated with the job) Achieving business numbers with the assigned line of channels (Basis location and market potential). People Management (Off roll) - Hiring, Retention Productivity. Sales Governance through compliance of systems and processes. Responsible for tracking, managing controlling PDD requirement compliance Reduction in customer complaints cancellation by ensuring that no miss-selling is being done. Understanding of CRM - Salesforce.com. Effectively engage with Credit, Operations, Risk within 2W/3W teams. To ensure TAT is maintained for case processing. 4. MAJOR CHALLENGES (Challenges faced on an on-going basis in carrying out the job) Training of self and their team below. Hiring right candidate. Smooth onboarding to help settle the employee we'll in BFL. Smooth onboarding of New Dealer/Partner with BFL Retention of Off-roll staff 5. DECISIONS (Key decisions taken by job holder at his/her end) Hiring of Off roll staff Approvals by coordinating with internal stake holders eg. Clearing cases Lead allocation Field activity planning and closure 6. INTERACTIONS (Key working relationships a job holder needs to have INSIDE and OUTSIDE the company to accomplish the job) Internal Clients Roles you need to interact with inside the organization to enable success in your day to day work Connect with various internal department ie product, credit, Ops, RCS compliance to process the file. Connect with HR department for hiring retention External Clients Roles you need to interact with outside the organization to enable success in your day to day work Engaging with customer. Mapping of market competition. 7. DIMENSIONS (Key numerical data which will reflect the scope and scale of activities concerning this job) Financial Dimensions (These should be quantifiable numerical amounts) From 45 to 70 Cases MOM (depending upon location and market potential) Other Dimensions (Significant volume dimensions associated with the job) Total Team Size: 9 Number of Direct Reports: 5 to 9 Number of Indirect Reports: NA Number of Outsourced employees: 5 to 9 Number of locations: 1 to 4 Number of products: 1 ie Two wheeler Loan Required Qualifications and Experience SKILLS AND KNOWLEDGE (Minimum acceptable proficiency for this job which best indicates the education and/or experience requirements of this job and not the incumbent) Educational Qualifications Qualifications - Graduate / Post Graduate Good command in excel is essential. Work Experience - 1 to 3 years of relevant experience in managing team Result oriented - Go getter attitude is must Should have collaborative work style to engage with peers colleagues across the company. Excellent Team management Interpersonal Skills. Excellent command over communication skills. Highly ambitious self-motivated

First link of management between the executors ie field staff and management. An effective communicator with exceptional relationship management skills with ability to relate to people at all levels of business and management. Delivery of business AOP objectives for the assigned geography. PRINCIPAL ACCOUNTABILITIES (Accountabilities associated with the job) Achieving business numbers with the assigned line of channels (Basis location and market potential). People Management (Off roll) - Hiring, Retention Productivity. Sales Governance through compliance of systems and processes. Responsible for tracking, managing controlling PDD requirement compliance Reduction in customer complaints cancellation by ensuring that no miss-selling is being done. Understanding of CRM - Salesforce.com. Effectively engage with Credit, Operations, Risk within 2W/3W teams. To ensure TAT is maintained for case processing. 4. MAJOR CHALLENGES (Challenges faced on an on-going basis in carrying out the job) Training of self and their team below. Hiring right candidate. Smooth onboarding to help settle the employee we'll in BFL. Smooth onboarding of New Dealer/Partner with BFL Retention of Off-roll staff 5. DECISIONS (Key decisions taken by job holder at his/her end) Hiring of Off roll staff Approvals by coordinating with internal stake holders eg. Clearing cases Lead allocation Field activity planning and closure 6. INTERACTIONS (Key working relationships a job holder needs to have INSIDE and OUTSIDE the company to accomplish the job) Internal Clients Roles you need to interact with inside the organization to enable success in your day to day work Connect with various internal department ie product, credit, Ops, RCS compliance to process the file. Connect with HR department for hiring retention External Clients Roles you need to interact with outside the organization to enable success in your day to day work Engaging with customer. Mapping of market competition. 7. DIMENSIONS (Key numerical data which will reflect the scope and scale of activities concerning this job) Financial Dimensions (These should be quantifiable numerical amounts) From 45 to 70 Cases MOM (depending upon location and market potential) Other Dimensions (Significant volume dimensions associated with the job) Total Team Size: 9 Number of Direct Reports: 5 to 9 Number of Indirect Reports: NA Number of Outsourced employees: 5 to 9 Number of locations: 1 to 4 Number of products: 1 ie Two wheeler Loan Required Qualifications and Experience SKILLS AND KNOWLEDGE (Minimum acceptable proficiency for this job which best indicates the education and/or experience requirements of this job and not the incumbent) Educational Qualifications Qualifications - Graduate / Post Graduate Good command in excel is essential. Work Experience - 1 to 3 years of relevant experience in managing team Result oriented - Go getter attitude is must Should have collaborative work style to engage with peers colleagues across the company. Excellent Team management Interpersonal Skills. Excellent command over communication skills. Highly ambitious self-motivated

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance.

Job Summary The Process Specialist-CDM/PV role involves managing and optimizing processes within Pharma Research & Development. The candidate will contribute to enhancing safety operations and pharmacovigilance case processing. With a hybrid work model and rotational shifts the role demands adaptability and technical expertise. The position does not require travel. Responsibilities Oversee the management and optimization of processes within Pharma Research & Development to ensure efficiency and compliance. Provide support in pharmacovigilance case processing ensuring accurate and timely documentation of safety data. Collaborate with cross-functional teams to enhance safety operations and improve overall process effectiveness. Analyze data and generate reports to support decision-making and strategic planning in pharmacovigilance activities. Implement best practices and innovative solutions to streamline processes and improve productivity. Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations. Facilitate communication and coordination between different departments to achieve seamless workflow and process integration. Monitor and evaluate process performance identifying areas for improvement and implementing corrective actions. Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution. Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations. Utilize technical skills to troubleshoot and resolve process-related issues minimizing disruptions and ensuring smooth operations. Contribute to the continuous improvement of processes by providing insights and recommendations based on data analysis. Engage in rotational shifts to provide consistent support and coverage across different time zones. Qualifications Possess a strong background in Pharma Research & Development with experience in pharmacovigilance case processing. Demonstrate proficiency in safety operations and regulatory compliance within the pharmaceutical industry. Exhibit excellent analytical skills and the ability to interpret complex data sets for informed decision-making. Show adaptability to work in a hybrid model and manage rotational shifts effectively. Have a keen eye for detail and a commitment to maintaining high standards of quality and accuracy. Display effective communication skills to collaborate with cross-functional teams and stakeholders. Be proactive in identifying process improvements and implementing innovative solutions. Hold a relevant degree in pharmaceutical sciences or a related field. Have a minimum of 2 years and a maximum of 4 years of experience in the pharmaceutical industry. Experience in PV Case Processing and Safety Ops is considered a valuable asset. Demonstrate the ability to work independently and as part of a team to achieve organizational goals. Show commitment to continuous learning and professional development in pharmacovigilance and safety operations. Be familiar with industry-standard software and tools used in pharmacovigilance and process management.

Aster Medcity is looking for Registered Nurse to join our dynamic team and embark on a rewarding career journey. Supervise nursing staff in a hospital or clinical settings. Oversee patient care, make management and budgetary decisions, set work schedules, coordinate meetings, and make personnel decisions. Recruit and train nurses and other health care professionals and maintain a facilitys records. Work with staff to apply emerging nursing theories to care delivery. Also implement state and federal regulatory guidelines for patient safety and educate staff about any changes in the laws and how they impact care delivery.