Pharmacovigilance Operations Manager

Job Summary

Leading patient safety operations, the full-time salaried Pharmacovigilance Operations Manager will manage global pharmacovigilance activities, ensure compliance with regulations, and maintain inspection-ready processes while collaborating with cross-functional teams and external partners.

Key Responsibilities

• Oversees global Patient Safety Operations and manages safety surveillance projects across various product categories
• Ensures compliance with ICH-GCP guidelines and regulatory requirements for safety reporting and documentation
• Monitors safety data trends and conducts signal detection and analysis for product safety evaluations

Required Qualifications

• Master's degree in Life Sciences, Pharmacology, Public Health, Nursing, or a related field with 6-8+ years of pharmacovigilance experience, or Bachelor's degree with 8+ years of relevant experience
• Progressive experience in pharmaceutical, biotechnology, or medical device environments
• Direct experience with end-to-end case processing and safety databases (Argus preferred)
• Strong understanding of global GVP regulations and pharmacovigilance compliance requirements
• Demonstrated ability to manage multiple priorities and lead projects independently