Scientist, Pharmacovigilance

Job Description This role performs Medical Review of Individual Case Safety Reports (ICSRs) which includes independent submissions to the FDA and increased responsibility of adverse event reporting, including quality control and medical analysis for both brand and generic products. Medical Review involves a thorough review of each case, utilizing advanced clinical interpretation of the case data to draw a causal relationship and formulate an accurate and complete medical opinion. Medical Reviews of ICSR's include post‑marketing products and investigational compounds. The position provides oversight to vendors for data entry and processing activities, including writing medical opinions, submitting to regulatory authorities, and conducting quality checks on vendor PV activities. The position ensures consistent and timely reporting of all adverse events received by Amneal to the regulatory authorities, maintaining knowledge of and implementation of pharmacovigilance best practices as well as regulatory guidance. The role is expected to contribute to the drafting and maintenance of SOPs related to pharmacovigilance activities. Essential Functions Medical review of Investigational New Drug (IND) serious adverse events and post‑marketing adverse event reports for spontaneous, medical literature cases for brand and generic products including case closure; review and submission of expedited ICSR's to relevant regulatory authorities. Review and provide oversight for all vendor activities performed in relation to ICSR's: case entry and assessment of listedness and seriousness, quality check and creation of AE medical narrative, interpretation and coding of AEs, medical conditions, medications, laboratory results and procedures using MedDra Dictionary. Collaborate with regulatory and PV Operations departments for AE data gathering, AE reconciliation and AE initiation; track and maintain timely closure and submission of AEs according to relevant regulatory authority regulations; audit participation when required with regulatory authorities. Safety label review and safety label update review for marketed products. Review of signal detection data and ADR summary every 6 months for each product. Conduct medical literature review for all Amneal products for special projects and perform oversight and analysis of literature review conducted by GPS vendor. Additional Responsibilities Medical Affairs: Team lead for medical affairs sub‑groups for MIRF (Medical Information Request Forms): manage information requests from HCPs submitted by IMPAX sales reps and MSLs and use SRLs, escalating to MSLs if required. Medical Affairs: Team lead for medical affairs sub‑groups for SERC (Scientific Evaluation and Review Committee): creating and updating standard response letters, scientific product data, FAQs, etc. for use by medical affairs and the drug safety call center; also reviews slide decks and materials used by field‑based Medical‑Science Liaisons (MSLs). Medical Affairs: Designated representative from the Medical Safety Science Department with technical expertise to verify the medical and scientific integrity of assets or communications and ensure accuracy, relevance, and scientific rigor. Qualifications Education: Medical Doctor Degree. Foreign medical graduates from WHO accredited schools acceptable. Required. Experience: 2 years or more in Drug Safety / Pharmacovigilance. The base salary for this position ranges from $90,000 to $110,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes it will pay for the position at the time of posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above‑market, diverse and robust health and insurance benefits, a significant 401(k) matching contribution, and employee well‑being programs that allow you to enjoy your career alongside life’s many commitments and opportunities. #J-18808-Ljbffr