Build and lead the pharmacovigilance (PV) function at Immuneering
Oversee safety data management & reporting including ICSR processing and regulatory submissions
Establish formal signal detection and risk management processes
Collaborate with cross-functional teams including Clinical Operations and Regulatory Affairs
Manage vendor relations and ensure compliance with safety data obligations
Foster a culture of patient safety and prepare/manage a PV department budget

M.D. required
Minimum 5-8 years of pharmacovigilance experience in the biopharmaceutical industry, with at least 1 years in a leadership or director-level role
Demonstrated expertise in global PV regulations and guidelines (FDA 21 CFR Parts 312/314/600, EMA Good Pharmacovigilance Practice, ICH E2A/E2D/E2E/E6)
Experience overseeing all aspects of ICSR management, aggregate report authorship, and signal detection
Oncology drug development experience, including familiarity with oncology-specific safety profiles
Track record of successful health authority interactions on PV matters
Experience managing or overseeing PV safety databases (e.g., Argus, ARISg, Oracle LSH)
Strong scientific acumen with the ability to independently conduct and communicate benefit-risk assessments
Excellent written and verbal communication skills; ability to distill complex safety information for diverse audiences

Immuneering Corporation

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