Senior Manager, Pharmacovigilance

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Manage end-to-end pharmacovigilance activities for oncology clinical trials, including case intake, processing, medical review and reporting of Individual Case Safety Reports (ICSRs).
• Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies.
• Manage external PV vendors and ensure timely, high-quality execution of contracted activities
• Support preparation and submission of Development Safety Update Reports (DSURs), periodic safety reports, and safety listings.
• Support ongoing safety surveillance, including aggregate data review, signal detection, and risk evaluation activities.
• Maintain Reference Safety Information (RSI) and contribute to benefit-risk assessment across development programs.
• Contribute to safety sections of clinical study protocol, informed consent forms (ICFs), investigator brochures (IBS) and clinical study reports (CSRs).
• Support IND/CTA submissions, amendments and regulatory interactions related to safety.
• Develop, implement and maintain pharmacovigilance SOPs, work instructions and training materials.
• Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed.
• Ensure PV systems and databases are compliant and inspection-ready.
• Provide functional leadership and subject-matter expertise for pharmacovigilance within cross-functional teams.
• Other duties as deemed necessary.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field required.
• 8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, including proven leadership roles.
• Strong knowledge of global PV regulations (FDA, EMA, APAC, ICH, GVP).
• Experience in signal management, safety data interpretation, and regulatory reporting.
• Oncology and autoimmune experience will be prioritized in this role.
• Demonstrated experience managing CROs and external vendors.
• MPH or pharmacoepidemiology training desirable.
• Demonstrated ability to operate independently while collaborating effectively in cross-functional teams.
• Excellent communication, analytical, and organizational skills.
• Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding.