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Director, Pharmacovigilance
Immuneering CorporationDirector of Pharmacovigilance at Immuneering leading safety surveillance strategies across oncology programs. Building the PV function at a clinical-stage biopharmaceutical company.
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Competitive compensation
- Equity participation
- Exceptional benefits
- Fully remote work environment
- Flexible, results-oriented culture
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
ICSR ManagementAggregate Report AuthorshipSignal DetectionBenefit-Risk AssessmentsRegulatory Submissions
Soft Skills
Excellent Written CommunicationExcellent Verbal Communication