Senior Director, Patient Safety & Pharmacovigilance Science
Corcept Therapeutics
August 12, 2026
Remote friendly (Redwood City, CA)
United States
Medical Affairs
Responsibilities:
- Develop and maintain strategies for signal detection and risk management across clinical and post-marketing settings.
- Lead proactive safety data reviews and analyses (e.g., case series reviews, data summaries, AE trend evaluations).
- Collaborate with safety physicians on signal detection and risk management.
- Review medical/scientific literature to support signal detection and aggregate reporting.
- Provide safety input to statistical analysis plans, data visualizations, and documents requiring in-depth safety analysis.
- Create and maintain product core safety information, including RMPs and CCDS.
- Lead preparation/development of global periodic aggregate safety reports.
- Contribute to and review safety sections of clinical documents (IB, protocols, clinical study reports).
- Facilitate cross-functional safety governance and alignment of safety strategy.
- Present safety data and expertise in key meetings (Health Authorities, DSMBs, Investigators).
- Lead/contribute to Health Authority and other safety-related query responses.
- Coach/mentor team members; oversee PV vendor performance and drive process improvement.
- Serve as SME for relevant PSPV Science processes.
Preferred Skills/Qualifications/Proficiencies:
- Working knowledge of Argus (or similar), MS Office, electronic data capture, MedDRA, WHO drug coding.
- Excellent presentation/communication/collaboration.
- In-depth global PV regulations/guidelines (ICH, GVP, FDA, EMA).
- Initiative in team settings; comfortable with ambiguity; self-motivated and timeline driven.
Preferred Education/Experience:
- PhD/PharmD or advanced degree preferred; BS/BA required. Epidemiology/public health training a plus.
- 8+ years patient safety/pharmacovigilance post-approval focus; at least 4 years clinical development.
- 2+ years supervisory/management in matrix, geographically dispersed organizations.
- 5+ years authoring/reviewing periodic and ad hoc safety reports (e.g., PSURs/DSURs).
- Experience with safety analysis, signal detection/surveillance, risk management, HA responses.
- Working knowledge of PV data systems (e.g., Oracle Argus).
- Experience with NDA/MAA filing; endocrinology experience a plus.
- Develop and maintain strategies for signal detection and risk management across clinical and post-marketing settings.
- Lead proactive safety data reviews and analyses (e.g., case series reviews, data summaries, AE trend evaluations).
- Collaborate with safety physicians on signal detection and risk management.
- Review medical/scientific literature to support signal detection and aggregate reporting.
- Provide safety input to statistical analysis plans, data visualizations, and documents requiring in-depth safety analysis.
- Create and maintain product core safety information, including RMPs and CCDS.
- Lead preparation/development of global periodic aggregate safety reports.
- Contribute to and review safety sections of clinical documents (IB, protocols, clinical study reports).
- Facilitate cross-functional safety governance and alignment of safety strategy.
- Present safety data and expertise in key meetings (Health Authorities, DSMBs, Investigators).
- Lead/contribute to Health Authority and other safety-related query responses.
- Coach/mentor team members; oversee PV vendor performance and drive process improvement.
- Serve as SME for relevant PSPV Science processes.
Preferred Skills/Qualifications/Proficiencies:
- Working knowledge of Argus (or similar), MS Office, electronic data capture, MedDRA, WHO drug coding.
- Excellent presentation/communication/collaboration.
- In-depth global PV regulations/guidelines (ICH, GVP, FDA, EMA).
- Initiative in team settings; comfortable with ambiguity; self-motivated and timeline driven.
Preferred Education/Experience:
- PhD/PharmD or advanced degree preferred; BS/BA required. Epidemiology/public health training a plus.
- 8+ years patient safety/pharmacovigilance post-approval focus; at least 4 years clinical development.
- 2+ years supervisory/management in matrix, geographically dispersed organizations.
- 5+ years authoring/reviewing periodic and ad hoc safety reports (e.g., PSURs/DSURs).
- Experience with safety analysis, signal detection/surveillance, risk management, HA responses.
- Working knowledge of PV data systems (e.g., Oracle Argus).
- Experience with NDA/MAA filing; endocrinology experience a plus.