Associate Medical Director, Pharmacovigilance
Immunome, Inc.
August 07, 2026
Remote friendly (Bothell, WA)
United States
Medical Affairs
Associate Medical Director, Pharmacovigilance (PV)
Responsibilities
- Provide medical oversight and leadership for safety activities for assigned products across development and post-marketing.
- Review and assess adverse events (AEs/SAEs), suspected adverse reactions, AESIs, deaths, discontinuations due to AEs, and other clinically relevant safety data.
- Support pharmacovigilance strategy development/implementation; lead benefit-risk evaluations and risk mitigation.
- Serve as key medical point of contact for safety-related decisions.
- Support safety data review and signal detection using clinical, spontaneous, literature, and external sources.
- Author/contribute to signal evaluation and safety assessment documents; track signals/topics through completion.
- Provide input into labeling recommendations and risk-benefit analyses.
- Support aggregate safety reporting (DSURs, PBRERs, IND annual reports, RMPs).
- Draft safety-related regulatory submission sections (INDs/NDAs/BLAs/MAAs); partner with RA on health authority interactions.
- Ensure compliance with pharmacovigilance requirements, ICH, and GVP standards.
- Collaborate cross-functionally; contribute to clinical safety endpoints; communicate safety updates internally.
- Participate in PV meetings/conferences; oversee PV vendors; support in-licensing/collaboration safety evaluations.
- Contribute to PV planning, inspection readiness, and process optimization.
Qualifications
- M.D./D.O. (board certification in Med Oncology, Hematology, or Immunology preferred).
- 3–5 years combined clinical and pharmacovigilance experience; 2+ years leadership in pharma/biotech.
- Global PV track record (pre- and post-marketing).
- Experience drafting safety regulatory documents (DSURs, PBRERs, RMPs) and interacting with health authorities.
- Oncology or immunology experience strongly preferred.
Skills
- Knowledge of global PV regulations and GVP; safety evaluation/signal detection/benefit-risk assessment.
- Strong analytical, written/verbal communication, and cross-functional influence.
Pay Range (WA)
- $222,288–$294,013 USD
Responsibilities
- Provide medical oversight and leadership for safety activities for assigned products across development and post-marketing.
- Review and assess adverse events (AEs/SAEs), suspected adverse reactions, AESIs, deaths, discontinuations due to AEs, and other clinically relevant safety data.
- Support pharmacovigilance strategy development/implementation; lead benefit-risk evaluations and risk mitigation.
- Serve as key medical point of contact for safety-related decisions.
- Support safety data review and signal detection using clinical, spontaneous, literature, and external sources.
- Author/contribute to signal evaluation and safety assessment documents; track signals/topics through completion.
- Provide input into labeling recommendations and risk-benefit analyses.
- Support aggregate safety reporting (DSURs, PBRERs, IND annual reports, RMPs).
- Draft safety-related regulatory submission sections (INDs/NDAs/BLAs/MAAs); partner with RA on health authority interactions.
- Ensure compliance with pharmacovigilance requirements, ICH, and GVP standards.
- Collaborate cross-functionally; contribute to clinical safety endpoints; communicate safety updates internally.
- Participate in PV meetings/conferences; oversee PV vendors; support in-licensing/collaboration safety evaluations.
- Contribute to PV planning, inspection readiness, and process optimization.
Qualifications
- M.D./D.O. (board certification in Med Oncology, Hematology, or Immunology preferred).
- 3–5 years combined clinical and pharmacovigilance experience; 2+ years leadership in pharma/biotech.
- Global PV track record (pre- and post-marketing).
- Experience drafting safety regulatory documents (DSURs, PBRERs, RMPs) and interacting with health authorities.
- Oncology or immunology experience strongly preferred.
Skills
- Knowledge of global PV regulations and GVP; safety evaluation/signal detection/benefit-risk assessment.
- Strong analytical, written/verbal communication, and cross-functional influence.
Pay Range (WA)
- $222,288–$294,013 USD