Senior Risk Management Scientist, Global Pharmacovigilance

Role Overview

• Provide scientific and operational support for global pharmacovigilance risk management and safety signal activities across the product lifecycle.
• Support the execution of risk management strategies, safety signal detection and evaluation, and regulatory compliance.
• Contribute to the development of Risk Management Plans, safety analytics, and governance deliverables.
• Prepare materials and presentations for the Product Safety Review Board (PSRB).
• Serve as an operational leader of the Drug Safety & Risk Management (DSRM).
• Coordinate and track reporting of safety issues to Product Safety Review Board (PSRB), Quality Management Review (QMR) and PV Leadership.

Requirements

• Advanced clinical degree (e.g., MD, DO, NP, PA, PharmD, PhD in a health-related field) required
• Significant Experience of pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience
• Global experience preferred
• Substantial Experience in PV / Safety
• Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance
• Strong knowledge in safety signal evaluation and responses to safety requests from Health Authorities

Benefits

• Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.
• Our salary and benefits are everything you’d expect from an organization with global strength and scale.
• You’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.