Job Description:
• 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
Requirements:
• 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
Benefits:
• Competitive compensation
• Equity participation
• Exceptional benefits
• Fully remote work environment
• Flexible, results-oriented culture