Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations

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
• Aids in the creation/revision of department standard operating procedures and work instructions
• Develops and delivers training for safety related topics
• Supports process improvement initiatives and safety systems activities
• Safety operations and/or safety science activities and projects, as necessary

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

Qualifications and Technical Proficiencies

• Bachelor's degree in healthcare or life sciences- degree such as RN or BSN, PharmD is preferred
• Minimum of 3 years Patient Safety & Pharmacovigivalence experience in a global environment
• Experience in post marketing safety operations preferred
• Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing

Pay

The pay range that the Company reasonably expects to pay for this position is $103,600 – $137,100; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

About the Role

Corcept is a company that has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our 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. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.