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 is responsible for overseeing drug safety and pharmacovigilance operations for clinical trials. This role ensures that safety reporting requirements and processes are established and maintained throughout the clinical trial phases (1-3). The position may be remote or hybrid, requiring occasional travel to support business needs.

Responsibilities

• Support the oversight of drug safety service providers to ensure compliance with global regulatory requirements and 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 (RN, BSN, PharmD) is required.
• Minimum of 5 years of Drug Safety/PV experience in a global environment.
• Experience in clinical and post-marketing safety operations preferred.
• Working knowledge of FDA, EU, and ICH guidelines for safety reporting and processing for clinical trials and post-marketing.

Nice-to-haves

• 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.

Benefits

• Competitive salary range of $144,800 - $212,900 based on experience and qualifications.