Senior Director, Patient Safety & Pharmacovigilance Science
Corcept Therapeutics
September 02, 2026
Remote friendly (Redwood City, CA)
United States
Operations
Responsibilities
- Develop and maintain strategies for signal detection and risk management across clinical and post-marketing settings; lead proactive safety data reviews/analyses (case series reviews, AE trend evaluations).
- Collaborate with safety physicians; review medical/scientific literature to support signal detection and aggregate reporting.
- Provide safety input to statistical analysis plans, safety visualizations, and regulatory documents.
- Create/maintain core safety information (RMPs, CCDSs); lead development of global periodic aggregate safety reports.
- Contribute to/review safety sections of clinical documents (IB, study protocols, clinical study reports).
- Facilitate cross-functional safety governance; establish relationships with senior stakeholders.
- Present safety data and expertise at key meetings (health authorities, DSMBs, investigators); lead/contribute to safety-related query responses.
- Coach/mentor team members; oversee PV vendor performance and drive process improvement.
- Serve as SME for relevant PSPV Science processes.
Qualifications & Preferred Skills
- BS/BA required (advanced degree such as PhD/PharmD preferred). Training/experience in epidemiology/public health beneficial.
- 8+ years patient safety/pharmacovigilance (post-approval focus) with at least 4 years clinical development.
- 2+ years supervisory/management experience in matrixed, geographically dispersed org.
- Experience authoring/reviewing periodic/ad hoc safety reports (e.g., PSURs/DSURs/Clinical Overviews/CSRs).
- Strong analytical reasoning; data analysis and presentation skills.
- Experience with safety analysis, signal detection/surveillance, risk management, and HA responses.
- Working knowledge of Argus (or similar), MS Office, eDC, MedDRA/WHO drug coding; PV regulations (ICH/GVP/FDA/EMA).
- NDA/MAA filing experience; endocrinology a plus.
- Ability to work in dynamic environments; strong communication/collaboration.
Pay range: $238,400–$315,600.
- Develop and maintain strategies for signal detection and risk management across clinical and post-marketing settings; lead proactive safety data reviews/analyses (case series reviews, AE trend evaluations).
- Collaborate with safety physicians; review medical/scientific literature to support signal detection and aggregate reporting.
- Provide safety input to statistical analysis plans, safety visualizations, and regulatory documents.
- Create/maintain core safety information (RMPs, CCDSs); lead development of global periodic aggregate safety reports.
- Contribute to/review safety sections of clinical documents (IB, study protocols, clinical study reports).
- Facilitate cross-functional safety governance; establish relationships with senior stakeholders.
- Present safety data and expertise at key meetings (health authorities, DSMBs, investigators); lead/contribute to safety-related query responses.
- Coach/mentor team members; oversee PV vendor performance and drive process improvement.
- Serve as SME for relevant PSPV Science processes.
Qualifications & Preferred Skills
- BS/BA required (advanced degree such as PhD/PharmD preferred). Training/experience in epidemiology/public health beneficial.
- 8+ years patient safety/pharmacovigilance (post-approval focus) with at least 4 years clinical development.
- 2+ years supervisory/management experience in matrixed, geographically dispersed org.
- Experience authoring/reviewing periodic/ad hoc safety reports (e.g., PSURs/DSURs/Clinical Overviews/CSRs).
- Strong analytical reasoning; data analysis and presentation skills.
- Experience with safety analysis, signal detection/surveillance, risk management, and HA responses.
- Working knowledge of Argus (or similar), MS Office, eDC, MedDRA/WHO drug coding; PV regulations (ICH/GVP/FDA/EMA).
- NDA/MAA filing experience; endocrinology a plus.
- Ability to work in dynamic environments; strong communication/collaboration.
Pay range: $238,400–$315,600.