Pharmacovigilance Director

Job Summary

To build and lead a pharmacovigilance function during a pivotal period of clinical growth, the full-time salaried Director, Pharmacovigilance will oversee safety surveillance strategies, establish PV systems and processes, and serve as the internal expert across clinical, regulatory, and medical affairs in a fully remote environment.

Key Responsibilities

• Oversee the processing, medical review, and regulatory submission of Individual Case Safety Reports (ICSRs) and ensure timely preparation of aggregate safety reports
• Establish and lead a formal signal detection process, conducting benefit-risk assessments and implementing risk management plans
• Collaborate with cross-functional teams to integrate safety considerations throughout the drug development lifecycle and manage vendor compliance

Required Qualifications

• M.D. required
• Minimum 5-8 years of pharmacovigilance experience in the biopharmaceutical industry, with at least 1 year in a leadership or director-level role
• Demonstrated expertise in global PV regulations and guidelines
• Oncology drug development experience, including familiarity with oncology-specific safety profiles
• Experience managing or overseeing PV safety databases