Job Description

Director, Pharmacovigilance

Immuneering Corporation is seeking an experienced Director, Pharmacovigilance to build and lead our pharmacovigilance 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

• Oversee receipt, processing, medical review, and regulatory submission of Individual Case Safety Reports (ICSRs), including serious adverse events (SAEs) and SUSARs.
• Ensure timely preparation and submission of aggregate safety reports, including DSURs, PSURs/PBRERs, and PADERs.
• Lead expedited and aggregate reporting to health authorities globally; maintain awareness of country-specific reporting requirements across trial sites.
• Oversee SAE reconciliation between the safety database and clinical trial databases.

Signal Detection & Risk Management

• Establish and lead a formal signal detection and management process, including regular review of internal safety data and external literature/regulatory sources.
• Conduct and document benefit-risk assessments; escalate emerging safety signals to relevant stakeholders and governance committees.
• Develop and implement risk minimization measures and risk management plans (RMPs/REMSs) as required.
• Prepare safety sections for Investigator Brochures (IBs), clinical study protocols, informed consent forms, and regulatory submissions.

Cross-Functional Collaboration

• Partner closely with Clinical Operations, Clinical Development, Regulatory Affairs, Data Management and Biostatistics to integrate safety considerations throughout the drug development lifecycle.
• Serve as the primary PV point of contact for health authority interactions on safety topics, including responses to queries and participation in safety-related meetings.
• Collaborate with Data Safety Monitoring Boards (DSMBs) and internal safety review committees, providing safety data summaries and expert input.

Vendor & CRO Oversight

• Work closely with PV CRO, safety database vendors, and other third-party service providers; ensure compliance with contractual and regulatory obligations.
• Manage PV agreements, including safety data exchange agreements (SDEAs) with partners and collaborators (e.g., Regeneron).
• Conduct oversight audits and quality checks of vendor-generated safety reports and database entries.

Team & Function Building

• Foster a culture of patient safety, quality, and continuous improvement.
• Prepare and manage a PV department budget.

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.

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