Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations
About The Position
The role supports drug safety and pharmacovigilance activities in the post-marketing setting, focusing on supporting case management activities, particularly on the oversight of quality and compliance of vendor/service provider activities. Corcept is headquartered in Redwood City, California. Corcept is singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Their commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Requirements
- Ability to work in a dynamic environment to meet patient and corporate needs
- Knowledge of Argus (or similar safety applications) and MedDRA and WHO Drug coding dictionaries
- Excellent communication and collaboration skills
- Ability to manage multiple projects in a fast-paced environment
- Bachelor's degree in healthcare or life sciences- degree such as RN or BSN, PharmD is preferred
- Minimum of 3 years Patient Safety & Pharmacovigilance experience in a global environment
- Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing
Nice To Haves
- Experience in post marketing safety operations preferred
Responsibilities
- Support the oversight of drug safety/pharmacovigilance service providers to ensure the collection, processing, reporting and reconciliation of adverse events reports in compliance with global regulatory requirements
- Perform in line and/or end of line quality review of adverse event reports
- Assists in the creation/revision of department standard operating procedures and work instructions
- Development and delivery of training for safety related topics
- Support process improvement initiatives and safety systems activities
- Support and participate in audits and inspections, including preparation activities
- Assist with safety operations and/or safety science activities and projects, as necessary
Benefits
- Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
