(Senior) Director, Drug Safety and Pharmacovigilance Operations

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

We are looking for an accomplished Pharmacovigilance (PV) Leader to spearhead the evolution of our drug safety framework as we enter Phase 3. Balancing strategic oversight of external partners with hands-on systems building, you will uphold the highest standards of scientific integrity and regulatory compliance to pave the way for successful regulatory filings and commercial launch. 

How you might spend your days 

• Collaborating with external partners, CROs, and affiliates to manage PV vendors and agreements, and Safety Management Plans as needed, to ensure consistent safety practices, reporting, and compliance across all programs
• Providing expert oversight for safety data review, including aggregate analyses, working closely with Regulatory Affairs to produce and submit periodic safety reports (e.g. DSURs, PSURs), individual reports (SUSARs, CIOMs), and responses to regulatory queries
• Working with Medical Monitors and Clinical Scientists to facilitate comprehensive safety signal detection, validation, and management, ensuring timely escalation and re