Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations

For more than 25 years, Corcept 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 .

The role supports drug safety and pharmacovigilance activities in post-marketing setting focusing on supporting case management activities, particularly focused on the oversight of quality and compliance of vendor/service provider activities.

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

Required Skills, Qualifications and Technical Proficiencies:

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

Education and Experience:

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

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

The pay range that the Company reasonably expects to pay for this position is $129,400-$152,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link .

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.

Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

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