Senior Director, Patient Safety & Pharmacovigilance Science

Responsibilities:
- Develop and maintain strategies for safety signal detection and risk management across clinical and post-marketing settings.
- Lead proactive safety data reviews/analyses (case series reviews, data summaries, AE trend evaluations) and collaborate with safety physicians.
- Review medical/scientific literature to support signal detection and aggregate reporting.
- Provide safety input to statistical analysis plans, data visualizations, and safety sections across regulatory documents.
- Create/maintain core safety information (RMPs, CCDS) and lead global periodic aggregate safety reports.
- Contribute to/review safety sections of clinical documents (IB, clinical protocols, clinical study reports).
- Facilitate cross-functional safety governance and build relationships with senior stakeholders.
- Present safety data and provide expertise at key meetings (health authorities, DSMBs, investigators); lead/contribute to health authority safety query responses.
- Coach/mentor team members; oversee PV vendor performance and drive continuous improvement.
- Serve as SME for relevant PSPV Science processes.

Qualifications & Preferred Skills:
- BS/BA required; PhD/PharmD/advanced degree preferred.
- 8+ years in patient safety/pharmacovigilance (post-approval focus) with at least 4 years clinical development.
- 2+ years supervisory/management experience in a matrix/dispersed org.
- 5+ years authoring/reviewing periodic/ad hoc safety reports (e.g., PSURs/DSURs/clinical overviews/CSRs).
- Strong analytical reasoning; experience with safety analysis, signal detection/surveillance, risk management, and HA responses.
- Working knowledge of Argus (or similar), MS Office, EDC systems, MedDRA/WHO coding dictionaries; strong PV regulatory knowledge (ICH/GVP/FDA/EMA).
- Experience with NDA/MAA filing; endocrinology experience is a plus.

Pay range: $238,400–$315,600.