Manager, Clinical Safety Operations

$144,800 - $212,900/Yr

Corcept Therapeutics - Redwood City, CA

Full-time - Mid Level

Remote - Redwood City, CA

Chemical Manufacturing

About the position

The Manager of Clinical Safety Operations at Corcept Therapeutics plays a crucial role in supporting drug safety and pharmacovigilance activities for clinical trials. This position is responsible for ensuring that safety reporting requirements and processes are established and maintained throughout the clinical trial phases (1-3). The role can be performed remotely within the United States or as a hybrid position in Redwood City, CA, with some travel required to support business needs.

Responsibilities

• Support the oversight of drug safety service providers to ensure compliance with global regulatory requirements and standard operating procedures (SOPs) for adverse event reports.
• Serve as a Safety Operations Lead on study management teams.
• Create, revise, and implement department SOPs, work instructions, and Safety Management Plans (SMPs).
• Develop and deliver training on safety-related topics for internal personnel and external vendors.
• Perform quality reviews of adverse event reports.
• Support process improvement initiatives and safety systems implementation/maintenance activities.
• Ensure the clinical trial master file (TMF) is maintained in an inspection-ready state for all safety-related documents.
• Support and participate in audits and inspections, including preparation activities.
• Assist with safety operations and/or safety science projects as necessary.

Requirements

• Bachelor's degree in healthcare or life sciences (e.g., RN, BSN, PharmD) is required.
• Minimum of 5 years of Drug Safety/PV experience in a global environment.
• Experience in both clinical and post-marketing safety operations is preferred.
• Working knowledge of FDA, EU, and ICH guidelines for safety reporting and processing for clinical trials and post-marketing.
• Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries.
• Excellent communication and collaboration skills in a multidisciplinary team.
• Ability to work independently and manage multiple projects in a dynamic, fast-paced environment.