Associate Director of Pharmacovigilance

Job Summary

A company is looking for an Associate Director, Pharmacovigilance.

Key Responsibilities

• Oversee pharmacovigilance activities for clinical programs and ensure compliance with regulatory requirements
• Manage safety data reviews, including adverse event reports, and facilitate DSMB and SRC meetings
• Ensure compliance with global pharmacovigilance regulations and manage quality events documentation

Required Qualifications

• PharmD or RN degree required
• Experience in pharmacovigilance or clinical development within the biotech or pharmaceutical industry
• Proven experience with adverse event review and supporting DSMBs and SRCs
• Strong knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
• Proficiency in Microsoft Office Suite and Argus safety database