Pharmacovigilance Scientist

Role: Pharmacovigilance (PV) Scientist supporting safety monitoring of Replimune’s oncology immunotherapy products. Objectives include analyzing safety data, managing signal detection, and ensuring compliance with global PV regulations. Responsibilities: independently and collaboratively perform safety data analyses, maintain signal tracking processes, support safety-related inquiries, liaise with clinical and medical teams, review coding, prepare safety reports (DSUR, PADER, PSUR), and contribute to PV documentation and SOP updates. Requirements: PharmD, MD, PhD, or equivalent healthcare degree; at least 4 years' PV or research experience; strong knowledge of drug development, MedDRA, and clinical safety databases; excellent communication and analytical skills. Preferred: familiarity with regulatory filings (BLA/MAA), PV systems, and risk management plans. High-Value: focus on cancer immunotherapies, pharmacovigilance, safety reporting, medical writing, and regulatory compliance within a biotech/pharma setting. Work setup involves potential travel for site inspections or meetings; reporting to Sr Director, Safety Risk Management & PV Sciences.