Associate Medical Director, Pharmacovigilance

Position Overview

The Associate Medical Director, Pharmacovigilance (PV) will provide medical leadership and oversight of safety management activities across Immunome’s early phase oncology portfolio. This position will provide safety oversight for the detection, evaluation, interpretation, and communication of safety information across assigned oncology assets. Supports driving proactive safety surveillance, risk management, and signal detection throughout the product lifecycle - from early clinical development through post-marketing. 

The ideal candidate will be a medically trained professional with an understanding of global pharmacovigilance regulations, and experience in a biotech or pharmaceutical setting. The individual should be comfortable working in a fast-paced, science-driven organization with investigational therapies, evolving safety profiles, and complex patient populations across internal departmental functions. 

Responsibilities

Leadership in Drug Safety 

• Provide medical oversight and leadership for all safety activities related to assigned products, ensuring patient safety across development and post-marketing phases. 
• Provide medical review, interpretation, and assessment of adverse events, serious adverse events, suspected adverse reactions, adverse events of special interest, deaths, discontinuations due to adverse events, and other clinically relevant safety data. 
• Support safety management teams to develop, implement, and refine pharmacovigilance strategies in alignment with corporate and regulatory objectives. 
• Proactively identify, assess, and manage emerging safety signals, leading benefit-risk evaluations and risk mitigation strategies. 
• Serve as the key medical point of contact for all safety-related decisions for assigned products, ensuring consistent, evidence-based assessments. 

Safety Data Evaluation and Signal Management 

• Support ongoing safety data review and signal detection using multiple data sources (clinical trial data, spontaneous reports, literature, and external databases). 
• Identify, evaluate, and escalate emerging safety concerns, including potential signals, clusters of events, increased frequency or severity of known risks, and events requiring risk mitigation. 
• Author or contribute to signal evaluation reports, safety assessment memos, safety topic reviews, and benefit-risk summaries. 
• Track assigned signals and safety topics through completion, ensuring timely documentation, governance review, and regulatory alignment. 
• Provide medical input into signal evaluation, risk-benefit analyses, and labeling recommendations. 
• Support preparation of aggregate safety reports, including Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), IND annual reports, and risk management plans (RMPs). 

Regulatory Strategy and Documentation 

• Draft safety-related sections of regulatory submissions including INDs, NDAs, BLAs, and MAAs. 
• Partner with RA during interactions with regulatory authorities (FDA, EMA, MHRA, etc.) on product safety matters. 
• Collaborate with Regulatory Affairs to ensure appropriate inclusion of safety information in the Investigator’s Brochure (IB), Informed Consent Forms (ICF), and other study documents. 
• Ensure compliance with all applicable pharmacovigilance requirements, ICH guidelines, and Good Pharmacovigilance Practice (GVP) standards.  

Cross-Functional Collaboration and Communication 

• Partner with Clinical Development, Biostatistics, and Medical Affairs to support signal detection, safety data analysis, and communication of emerging findings. 
• Participate in clinical study design by contributing to safety endpoint development and monitoring plans. 
• Collaborate with Translational Sciences and CMC functions to understand mechanistic insights related to safety s