Immunome, Inc.
Associate Medical Director, Pharmacovigilance
Bothell, Washington, United States · Director
Sponsorship not specified$222k-$294kDetected 1 day ago
Data AnalysisComplianceProduct ManagementBusiness DevelopmentFDA RegulatoryPharmacovigilanceExperimental DesignLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs
About the role
- 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.
- Within the Pharmacovigilance function, they will be responsible for driving proactive safety surveillance, risk management, and signal detection throughout the product lifecycle - from early clinical development through post-marketing.
Responsibilities
- Support safety management teams to develop, implement, and refine pharmacovigilance strategies in alignment with corporate and regulatory objectives.
- Support ongoing safety data review and signal detection using multiple data sources (clinical trial data, spontaneous reports, literature, and external databases).
- 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.
- 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 signals.
- Engage with external safety experts, key opinion leaders (KOLs), and partners to advance understanding of drug safety and risk mitigation strategies.
- Support business development activities by providing safety evaluations of potential in-licensing or collaboration opportunities.
Requirements
- 5 years of combined clinical and pharmacovigilance experience, including 2+ years in a leadership capacity within the pharmaceutical or biotechnology industry or equivalent.
- Proven track record in global pharmacovigilance, including experience managing pre- and post-marketing products.
- Knowledge and Skills
- Working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, MHRA) and GVP standards.
- Strong analytical and strategic thinking skills with the ability to synthesize complex safety data.
- ability to effectively interact with internal teams, regulators, and external stakeholders.
- Demonstrated ability to influence cross-functional teams and executive leadership.
- M.D., D.O., or equivalent medical degree
- board certification in Medical Oncology, Hematology, or Immunology preferred.
- Minimum of 3 - 5 years of combined clinical and pharmacovigilance experience, including 2+ years in a leadership capacity within the pharmaceutical or biotechnology industry or equivalent.
- Experience drafting safety-related regulatory submissions (DSURs, PBRERs, RMPs) and participating in health authority interactions.
- Experience in safety data evaluation, signal detection, and benefit-risk assessment methodologies.
- Experience developing and managing safety management teams and vendor partnerships.
- Strong written and verbal communication skills
- Ability to manage multiple priorities and projects in a dynamic, fast-paced biotech environment.
Nice to have
- Oncology or immunology experience strongly preferred.
Compensation
- 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).
Benefits
- Provide medical oversight and leadership for all safety activities related to assigned products, ensuring patient safety across development and post-marketing phases.
- 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.
- Author or contribute to signal evaluation reports, safety assessment memos, safety topic reviews, and benefit-risk summaries.
- Provide medical input into signal evaluation, risk-benefit analyses, and labeling recommendations.
- Partner with Clinical Development, Biostatistics, and Medical Affairs to support signal detection, safety data analysis, and communication of emerging findings.
Apply directly at Immunome, Inc. →Create a free account for alerts like thisView Immunome, Inc. immigration profile
This listing is sourced directly from Immunome, Inc.'s careers page and normalized into a canonical job model.