Senior Manager Pharmacovigilance Operations

Job Summary

A company is looking for a Senior Manager Safety PV Ops.

Key Responsibilities

• Lead global ICSR activities to ensure compliance with regulations
• Manage PV operations activities from study start-up to closure
• Oversee compliance processes and training for external case management vendors

Required Qualifications

• BS/BA degree in a related discipline with a minimum of 10 years of experience, or equivalent combination of education and experience
• At least 8 years of experience in Pharmacovigilance Operations
• Working knowledge of international regulatory Adverse Event Reporting requirements
• Proven experience in guiding PV vendor staff
• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices