Associate Director, Patient Safety Scientist

Overview

In this role you will lead pharmacovigilance and risk management for designated products, collaborating with the Global Safety Physician and PV scientists. You will author safety documents, provide PV input for regulatory reports, and lead safety reviews with cross-functional teams. You’ll present safety data at external meetings and guide smaller projects as a SSAMT leader.

The position involves evaluating safety signals, contributing to regulatory submissions, and mentoring junior team members within a patient-safety focused environment.

• Lead proactive pharmacovigilance and risk management planning for designated products, in partnership with GSP and colleagues.
• Represent Patient Safety on cross-functional development and marketed product teams.
• Present safety information at external meetings.
• Act as Safety Strategy and Management Team leader for smaller/less complex projects.
• Present issues to SIRC and lead data evaluation discussions with the SIRC Chair and stakeholders.
• Produce accurate safety evaluation documents in response to internal/regulatory requests.
• Collaborate with GSP and Clinical to author RSI and coordinate timelines.
• Evaluate clinical implications of safety data across pre-clinical, clinical, and literature sources to establish safety profiles.
• Author or provide strategic input for periodic regulatory documents (PBRERs, PSURs, DSURs).
• Contribute to regulatory submissions (NDA/BLA, MAA) with GSP and experts.
• Contribute to PS component of contracts with third parties to ensure quality and integrity.
• Train junior team members in PV tools and systems.

• Life sciences/pharmacy/nursing degree
• Intermediate knowledge of PV regulations
• Fluent in written and verbal English
• MD, MSc/PhD in scientific discipline preferred
• Basic understanding of epidemiology data preferred

• Cross-functional collaboration
• Strong communication and presentation
• Leadership and mentorship
• Pharmacovigilance regulations and guidelines
• RSI, PBRER/PSUR/DSUR authoring and oversight
• Safety data evaluation and signal detection