Director, Pharmacovigilance

Director, Pharmacovigilance

Immuneering is seeking an experienced Director, Pharmacovigilance to build and lead our pharmacovigilance (PV) function during a pivotal period of clinical growth. Reporting to senior leadership, this individual will be responsible for the end-to-end safety surveillance strategy across our oncology portfolio, including our global Phase 3 program. The Director will establish PV systems, policies, and processes; oversee safety data collection and reporting; and serve as the internal PV expert across clinical, regulatory, and medical affairs functions. This is a high-impact, hands-on leadership role ideal for a seasoned PV professional eager to shape a function from the ground up at a dynamic, science-led company.

Key Responsibilities

• Safety Data Management & Reporting
• Signal Detection & Risk Management
• Cross-Functional Collaboration
• Vendor & CRO Oversight
• Team & Function Building

Qualifications

Required

• 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.

Preferred

• Experience building or significantly scaling a PV function at a clinical-stage company.
• QPPV designation or experience supporting QPPV responsibilities in the EU.
• Familiarity with safety considerations in Phase 3 global oncology trials and NDA/BLA submissions.
• Experience with RAS/RAF/MEK pathway inhibitors or kinase inhibitors.
• Fluency with regulatory intelligence tools and signal detection software.
• Prior experience managing external PV partnerships and safety data exchange agreements.
• Model Immuneering values: Data Rules, All in, Care, Own It (accountable) and Humble

What We Offer

• The opportunity to build and lead a critical function at a pivotal inflection point in Immuneering's clinical journey.
• A collaborative, science-first culture that values expertise, initiative, and patient impact.
• Competitive compensation, equity participation, and exceptional benefits.
• Fully remote work environment with a flexible, results-oriented culture.

Equal Opportunity Employer

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.