6 Pharmacovigilance Operations Jobs

As a Pharmacovigilance Services Associate at Accenture, your role will involve supporting the Life Sciences R&D vertical by managing the Affiliate Mailbox, reconciling reports, and performing follow-up attempts for both Serious and Non-serious cases. You will be responsible for tasks such as case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database according to client guidelines and global regulatory requirements. You are expected to have a Bachelor of Pharmacy or Master of Pharmacy qualification and possess 1 to 3 years of experience in Pharmacovigilance Operations. In this position, you will work closely with the Clinical, Pharmacovigilance & Regulatory sub-offerings to assist leading biopharma companies in realizing their vision and improving outcomes for patients. Your responsibilities as a Drug Safety Associate will involve solving routine problems by following general guidelines and precedents. Your interactions will primarily be within your team and with your direct supervisor. You will receive detailed to moderate levels of instruction for daily tasks and new assignments. Your decisions will impact your individual work within the focused scope of your team. Please be aware that this role may require you to work in rotational shifts. If you are looking to contribute as an individual team member in the field of Pharmacovigilance and drug safety surveillance, this position offers an opportunity to work with cutting-edge technologies and make a meaningful impact in the healthcare industry.,

As a Pharmacovigilance Services Associate at Accenture, you will play a crucial role in Pharmacovigilance Operations, focusing on Drug Safety Surveillance. You should hold a Bachelor of Pharmacy or Master of Pharmacy degree and have 1 to 3 years of relevant experience. Accenture is a global professional services company known for its expertise in digital, cloud, and security solutions. With a workforce of 699,000 individuals across 120 countries, we specialize in Strategy and Consulting, Technology, and Operations services. At Accenture, we leverage technology and human ingenuity to drive value and success for our clients, shareholders, partners, and communities. In this role, you will be part of the Life Sciences R&D vertical, supporting services that cover the entire life sciences landscape. From research laboratories to clinical trials support and regulatory services, your responsibilities will include pharmacovigilance and patient services solutions. You will collaborate with leading biopharma companies to bring their visions to life and enhance patient outcomes by integrating scientific expertise with insights into the patient experience. Your primary responsibilities will involve managing the Affiliate Mailbox, reconciling reports, and following up on Serious and Non-serious cases. You will be tasked with case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in compliance with client guidelines and global regulatory requirements. As a Drug Safety Associate, you will be expected to solve routine problems using general guidelines and referrals, with interactions primarily within your team and direct supervisor. You will receive detailed instructions for daily tasks and new assignments, and your decisions will directly impact your work. Working as an individual contributor within a focused team, you may be required to work in rotational shifts. If you are passionate about pharmacovigilance operations, drug safety surveillance, and making a positive impact in the life sciences industry, this role at Accenture offers an exciting opportunity to contribute to cutting-edge solutions that improve patient outcomes and drive innovation.,

As a Pharmacovigilance Services Associate at Accenture, you will be responsible for supporting Pharmacovigilance Operations, focusing on drug safety surveillance. With a qualification of Bachelor of Pharmacy or Master of Pharmacy and 1 to 3 years of experience, you will play a crucial role in the management of the Affiliate Mailbox, reconciliation of reports, and conducting follow-up activities for both Serious and Non-serious cases. Your responsibilities will include case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in the safety database as per client guidelines and global regulatory requirements. Aligned with Accenture's Life Sciences R&D vertical, you will be part of a team that provides services across the life sciences enterprise, supporting research laboratories, clinical trials, regulatory services, pharmacovigilance, and patient solutions. By collaborating with leading biopharma companies, you will contribute to improving outcomes by focusing on patient-centric approaches and leveraging scientific expertise to enhance patient experiences. In this role, you will solve routine problems with guidance from general guidelines and precedents. Your interactions will primarily be within your team and direct supervisor, and you will receive detailed instructions for daily tasks and new assignments. Your decisions will impact your own work as you work as an individual contributor within a focused scope of work. Please note that this position may require you to work in rotational shifts. If you are a detail-oriented individual with a background in pharmacovigilance and a passion for drug safety, this role offers an opportunity to contribute to the advancement of healthcare through the convergence of technology and human ingenuity. Join Accenture in delivering on the promise of technology and creating shared success for clients, partners, and communities worldwide.,

You will be working as a Pharmacovigilance Services New Associate at Accenture, a global professional services company with expertise in digital, cloud, and security solutions across various industries. As part of the Life Sciences R&D vertical, you will support biopharma companies in enhancing patient outcomes by integrating scientific knowledge with patient insights. Your responsibilities will include managing the Affiliate Mailbox, reconciling reports, and performing follow-up activities for both Serious and Non-serious cases. You will be responsible for case identification, data entry, MedDRA coding, processing, submission, and follow-ups for ICSRs in the safety database according to client guidelines and global regulatory requirements. In this role, you will solve routine problems based on guidelines and precedents, primarily interacting with your team and supervisor. You will receive detailed instructions for your tasks, and your decisions will be closely supervised, impacting your own work within a predetermined scope. Please note that rotational shifts may be required for this position. Qualifications required for this role include a BSc or Bachelor of Pharmacy degree, with proficiency in English (International). Ideally, you should have 0 to 1 years of experience in Pharmacovigilance Operations, focusing on Pharmacovigilance & Drug Safety Surveillance.,

What you will do This position plays a role in the authoring, compilation and peer review of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Compilation and authoring of PASRs Coordinate and schedule all meetings with cross-functional collaborators to ensure effective collaboration and alignment Drive report timelines and advance risks or delays to team leads or management Collaborate with cross-functional collaborators and external business partners to collect PASR contributions and compile into PASR template. Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. Maintain and archive accurate records and documentation throughout the report process. Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Responsible for the generation, including authoring of safety sections of all PASRs, including publishing approvals, metrics generation and archiving of source documents. Responsible for the scheduling and lead of all PASR meetings throughout PASR production Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support audit and inspection deliverables, including but not limited to information requests and response QC. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelors degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Understands and interprets data/information and its practical application Knowledge of scientific/technical writing and editing Excellent English written/oral communication, and strong time and project management skills Strategic approach, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations. Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting Ability to effectively manage competing priorities and timelines Strong leadership skills, independence, networking and influencing skills Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e.g. Veeva Vault Experience in use of AI and prompts would be useful Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic / aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelors / Masters degree in Health/Life Sciences with minimum 2 - 3 years of relevant work experience Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports.

What you will do This position plays a role in the authoring, compilation and peer review of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. Incompliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. In addition, this role has oversite of a team of Periodic Report Specialists. Key Responsibilities: Management responsibility for a team of Periodic Report Specialists Supervision of a team of Periodic Report Specialists in Amgen India with Periodic Report responsibilities Act as primary point of contact for the reports, present anticipated challenges and propose remediation and advance unresolved issues impacting deliverables. Act as a writing coach, provide regular quality feedback, and share standard methodologies with PRS for promoting the use of clear and concise writing and adherence to style guides and templates as applicable. Ensure compliance of operations with governing regulatory requirements. Compilation and authoring of PASRs Coordinate and schedule all meetings with cross-functional collaborators to ensure effective collaboration and alignment Drive report timelines and advance risks or delays to team leads or management Collaborate with cross-functional collaborators and external business partners to collect PASR contributions and compile into PASR template. Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. Maintain and archive accurate records and documentation throughout the report process Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Management of a team of Periodic Report Specialists Responsible for the generation, including authoring of safety sections of all PASRs, including publishing approvals, metrics generation and archiving of source documents. Responsible for the scheduling and lead of all PASR meetings throughout PASR production Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support audit and inspection deliverables, including but not limited to information requests and response QC. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 4 to 6 years of pharmaceutical, biotech or regulatory authority experince in a research and development setting experience OR Bachelors degree and 6 to 8 years ofpharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 10 to 12 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Understands and interprets data/information and its practical application Knowledge of scientific/technical writing and editing Excellent English written/oral communication, and strong time and project management skills Strategic approach, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations. Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting Ability to effectively manage competing priorities and timelines Strong leadership skills, independence, networking and influencing skills Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e.g. Veeva Vault Experience in use of AI and prompts would be useful Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic / aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 5 - 7 years of relevant work experience including 5 years of experience in periodic aggregate safety report writing OR Bachelors / Masters degree in Health/Life Sciences with minimum 4 years of Experience in managing personnel directly or providing leadership by guiding teams, overseeing projects or programs, or directing resource allocation. Overall 5 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports.