Associate Medical Director, Pharmacovigilance
Immunome, Inc.
August 29, 2026
Remote friendly (Bothell, WA)
United States
Medical Affairs
Associate Medical Director, Pharmacovigilance (PV)
Responsibilities
- Provide medical oversight and leadership for all safety activities for assigned oncology products across development and post-marketing.
- Perform medical review/interpretation of adverse events, serious adverse events, suspected adverse reactions, AESI, deaths, discontinuations due to AEs, and other clinically relevant safety data.
- Develop/refine PV strategies aligned to corporate/regulatory objectives.
- Proactively identify, assess, and manage emerging safety signals; lead benefit-risk evaluations and risk mitigation.
- Serve as key medical point of contact for safety decisions.
- Support safety data review and signal detection using clinical trial data, spontaneous reports, literature, and external databases.
- Author/contribute to signal evaluation reports and benefit-risk summaries; track signals/topics through completion.
- Provide input into signal evaluation, risk-benefit analyses, and labeling recommendations.
- Support aggregate safety reporting (e.g., DSURs, PBRERs, IND annual reports, RMPs).
- Draft safety sections for IND/NDA/BLA/MAA; partner with RA on regulator interactions; collaborate on IB/ICF and other study documents; ensure compliance with PV requirements, ICH, and GVP.
- Partner cross-functionally (Clinical Development, Biostatistics, Medical Affairs, Translational Sciences, CMC); communicate safety updates.
- Represent PV externally; oversee PV vendors; support business development safety evaluations.
Qualifications/Skills
- MD/DO (or equivalent); board certification preferred in Med Oncology, Hematology, or Immunology.
- 3–5 years combined clinical + PV experience; 2+ years leadership in pharma/biotech.
- Global PV experience (pre-/post-marketing).
- Experience drafting DSURs/PBRERs/RMPs and interacting with health authorities.
- Oncology/immunology preferred.
- Working knowledge of global PV regulations (FDA/EMA/ICH/MHRA) and GVP; signal detection and benefit-risk assessment; strong analytical, communication, and cross-functional leadership.
Pay Range
- $222,288 - $294,013 USD
Responsibilities
- Provide medical oversight and leadership for all safety activities for assigned oncology products across development and post-marketing.
- Perform medical review/interpretation of adverse events, serious adverse events, suspected adverse reactions, AESI, deaths, discontinuations due to AEs, and other clinically relevant safety data.
- Develop/refine PV strategies aligned to corporate/regulatory objectives.
- Proactively identify, assess, and manage emerging safety signals; lead benefit-risk evaluations and risk mitigation.
- Serve as key medical point of contact for safety decisions.
- Support safety data review and signal detection using clinical trial data, spontaneous reports, literature, and external databases.
- Author/contribute to signal evaluation reports and benefit-risk summaries; track signals/topics through completion.
- Provide input into signal evaluation, risk-benefit analyses, and labeling recommendations.
- Support aggregate safety reporting (e.g., DSURs, PBRERs, IND annual reports, RMPs).
- Draft safety sections for IND/NDA/BLA/MAA; partner with RA on regulator interactions; collaborate on IB/ICF and other study documents; ensure compliance with PV requirements, ICH, and GVP.
- Partner cross-functionally (Clinical Development, Biostatistics, Medical Affairs, Translational Sciences, CMC); communicate safety updates.
- Represent PV externally; oversee PV vendors; support business development safety evaluations.
Qualifications/Skills
- MD/DO (or equivalent); board certification preferred in Med Oncology, Hematology, or Immunology.
- 3–5 years combined clinical + PV experience; 2+ years leadership in pharma/biotech.
- Global PV experience (pre-/post-marketing).
- Experience drafting DSURs/PBRERs/RMPs and interacting with health authorities.
- Oncology/immunology preferred.
- Working knowledge of global PV regulations (FDA/EMA/ICH/MHRA) and GVP; signal detection and benefit-risk assessment; strong analytical, communication, and cross-functional leadership.
Pay Range
- $222,288 - $294,013 USD