US Licensed Regional Pharmacovigilance Lead

Job Summary

Serving as a scientific expert and pharmacovigilance resource, the full-time US Licensed Regional Pharmacovigilance Lead will manage compliance with local safety regulatory requirements, enhance pharmacovigilance processes, and collaborate closely with cross-functional teams in a remote environment.

Key responsibilities

• Act as the main point of contact for pharmacovigilance, partnering with key stakeholders in the assigned region
• Establish and maintain the pharmacovigilance system specific to the country/region while promoting compliance with safety obligations
• Support the Head of Regional PV in harmonizing processes and managing innovation projects to increase team efficiency

Required qualifications

• Master's degree in pharmacy, nursing, healthcare, or a related life-science field (PharmD or MD is a plus)
• 10-15 years of experience in the pharmaceutical/biotech industry, with at least 8 years in pharmacovigilance/drug safety
• Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
• Understanding of the drug development process and GXP quality and compliance requirements
• Candidates must be located in the EST time zone to be considered for this role