Director, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and develop the pharmacovigilance (PV) function at Immuneering.

• Supervise the management and reporting of safety data, including ICSR processing and regulatory submissions.

• Implement formal processes for signal detection and risk management.

• Collaborate with cross-functional teams, including Clinical Operations and Regulatory Affairs.

• Oversee vendor relationships and ensure adherence to safety data responsibilities.

• Promote a culture centered on patient safety while preparing and managing a budget for the PV department.

⛳️ Requirements

• An M.D. degree is required.

• A minimum of 5-8 years of experience in pharmacovigilance within the biopharmaceutical sector, with at least 1 year in a leadership or director-level position.

• Proven knowledge of global PV regulations and guidelines (FDA 21 CFR Parts 312/314/600, EMA Good Pharmacovigilance Practice, ICH E2A/E2D/E2E/E6).

• Experience in managing all facets of ICSR processes, creating aggregate reports, and conducting signal detection.

• Familiarity with oncology drug development, including knowledge of oncology-specific safety profiles.

• A history of successful interactions with health authorities regarding PV issues.

• Experience in managing or supervising PV safety databases (e.g., Argus, ARISg, Oracle LSH).

• Strong scientific knowledge with the capability to independently carry out and communicate benefit-risk assessments.

• Excellent written and verbal communication skills, with the ability to simplify intricate safety information for various audiences.

🏝️ Benefits

• Competitive salary.

• Equity participation.

• Outstanding benefits.

• Fully remote work setting.

• Flexible, results-oriented work culture.