Corcepttherapeutics
Specialist I, Patient Safety and Pharmacovigilance Operations
Redwood City, California, United States. Posted a month ago
The role
This role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in postmarketing and clinical trial settings. The person will manage shared PSPV mailboxes and intake channels to identify, document, and route safety information.
What you will do
- Monitor and manage assigned PSPV shared mailboxes and intake channels
- Perform initial review/triage of incoming information to identify potential adverse events, serious adverse events, product quality complaints, and special situations
- Identify potential Individual Case Safety Reports and ensure routing to appropriate teams
- Categorize, assign, route, file, and archive mailbox communications
- Prioritize and escalate serious, urgent, medically significant, or time-sensitive safety information
- Perform routine reconciliation of PSPV mailboxes and intake channels
- 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
- Perform additional PSPV projects and activities as assigned
Required qualifications
- Applicants must be currently authorized to work in the United States on a full-time basis
Nice to have
- 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
- 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
About the company
Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.