Senior Specialist I - Postmarketing Patient Safety & Pharmacovigilance

4w1 month ago

Corcept Therapeutics

Redwood City, US · Full-time · $103,600 – $137,100

About this role

Corcept Therapeutics is singularly focused on the science of cortisol, a powerful hormone that can play a role in a broad range of diseases. This role supports drug safety and pharmacovigilance activities in the post-marketing setting, focusing on case management and oversight of quality and compliance of vendor and service provider activities.

The specialist performs in-line and end-of-line quality review of adverse event reports and supports oversight of drug safety service providers. They assist in creating and revising department standard operating procedures and work instructions, and develop and deliver training for safety related topics.

The role also supports process improvement initiatives and safety systems activities, and participates in audits and inspections, including preparation activities. This work requires the ability to work in a dynamic, fast-paced environment to meet patient and corporate needs while complying with global regulatory requirements.

Corcept's commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS, and liver disease, this role offers the opportunity to contribute to patient safety for 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.
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.

Responsibilities

Support oversight of drug safety/pharmacovigilance service providers to ensure collection, processing, reporting and reconciliation of adverse event reports in compliance with global regulatory requirements.
Perform in-line and/or end-of-line quality review of adverse event reports.
Assist in the creation/revision of department standard operating procedures and work instructions.
Develop and deliver 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.