Associate Director, Pharmacovigilance Scientist

Role: Associate Director, Pharmacovigilance Scientist, supporting safety evaluation and pharmacovigilance activities for Candel's cancer immunotherapies across clinical development and post-marketing phases. Responsibilities: review and approve serious adverse event reports in Argus, author safety assessments, contribute to signal detection, safety summaries, and regulatory documents; support safety monitoring plans, SOPs, and vendor oversight; collaborate on safety data review, benefit-risk assessments, and regulatory responses. Requirements: advanced degree in health or life sciences (PharmD, MPH, etc.); 8+ years in pharmacovigilance, clinical safety, or drug development within biotech/pharma/CRO, preferably with oncology or gene therapy experience; proficient in global PV regulations, safety databases (Argus), and safety data review; strong scientific, medical, and regulatory writing skills; excellent communication and organizational abilities. HighValue: oncology immunotherapies, gene-mediated therapy, clinical-stage, safety database management, signal detection, global PV compliance. WorkSetup: remote or hybrid Needham, MA; no travel specified.