Specialist I, Patient Safety and Pharmacovigilance Operations
Corcept Therapeutics
Summary
This role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in the postmarketing (PM) and clinical trial (CT) setting. The role is primarily responsible for the daily management of shared PSPV mailboxes and other safety intake channels, ensuring incoming communications are reviewed promptly, potential safety information is identified, and items are appropriately documented, routed, tracked, and escalated in accordance with established procedures and regulatory timelines.
Job description
Responsibilities
- Monitor and manage assigned PSPV shared mailboxes and intake channels, ensuring timely review and disposition of incoming reports and communications
- Perform initial review/triage of incoming information to identify potential adverse events (AEs), serious adverse events (SAEs), product quality complaints (PQCs), special situations, and other safety-relevant information
- Identify potential Individual Case Safety Reports (ICSRs) and ensure information is routed to the appropriate case-processing team or workflow within required timelines
- Categorize, assign, route, file, and archive mailbox communications according to established procedures
- Prioritize and escalate serious, urgent, medically significant, or time-sensitive safety information as required
- Perform routine reconciliation of PSPV mailboxes and intake channels/sources to confirm potentially reportable information has been appropriately identified, received and processed
- Support the development of training materials
- Track and archive safety-related training for internal teams and vendors
- Assist with audits, regulatory inspections, and inspection-readiness activities by providing intake records and supporting documentation, as needed
- Perform additional PSPV projects and activities as assigned
Preferred Skills, Qualifications and Technical Proficiencies
- Ability to work in a dynamic environment to meet patient and corporate needs
- Excellent communication skills (verbal and written)
- Ability to collaborate with cross-functional teams and support multiple projects in a fast-paced environment
- Able to travel for up to 10% of time
- Flexibility to be in office more than 3 days week to meet any business needs (e.g., audits, regulatory inspections)
Preferred Education and Experience
- Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD
- 1+ years in healthcare setting, pharma or biotech company
- Familiarity with global pharmacovigilance regulations and safety-reporting requirements is desirable
Requirements
- Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD
- 1+ years in healthcare setting, pharma or biotech company
- Familiarity with global pharmacovigilance regulations and safety-reporting requirements is desirable
- Ability to work in a dynamic environment to meet patient and corporate needs
- Excellent communication skills (verbal and written)
- Ability to collaborate with cross-functional teams and support multiple projects in a fast-paced environment
- Able to travel for up to 10% of time
- Flexibility to be in office more than 3 days week to meet any business needs (e.g., audits, regulatory inspections)
Company overview
Corcept Therapeutics Inc. is a commercial-stage pharmaceutical company founded in 1998 and headquartered in Redwood City, California. The company specializes in the discovery, development, and commercialization of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effects of the hormone cortisol. Corcept's primary focus is on addressing the adverse effects of excess cortisol, which can lead to life-threatening conditions including Cushing's syndrome, various cancers, diabetes, and neurological disorders. The company's flagship product is Korlym (mifepristone), the first FDA-approved oral therapy for treating hyperglycemia in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance. With approximately 500 employees, Corcept has developed a large portfolio of proprietary compounds that selectively modulate cortisol effects without compromising progesterone function. The company maintains extensive intellectual property covering its selective cortisol modulators and continues to advance clinical trials for potential treatments of hypercortisolism, advanced ovarian cancer, prostate cancer, ALS, and MASH.