Manager, Clinical Safety Operations

Summary

Join Corcept Therapeutics as the Manager of Clinical Safety Operations, supporting drug safety and pharmacovigilance for clinical trials (Phase 1-3). You will ensure safety reporting compliance with global regulations and SOPs. This role may be remote within the US or hybrid in Redwood City, CA, with up to 20% travel. Responsibilities include overseeing service providers, leading study teams, developing SOPs, delivering training, performing quality reviews, and supporting process improvements. The position requires a Bachelor's degree in healthcare or life sciences and 5+ years of drug safety/PV experience in a global environment. Preferred qualifications include Argus knowledge, excellent communication skills, and experience in both clinical and post-marketing safety operations.

Requirements

• Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD is required
• Minimum of 5 years Drug Safety/PV experience in a global environment
• Applicants must be currently authorized to work in the United States on a full-time basis

Responsibilities

• Support the oversight of drug safety service providers to ensure collection, processing, reporting and reconciliation of adverse events reports is compliant with global regulatory requirements and standard operating procedures (SOPs)
• Serve as a Safety Operations Lead on study management team(s)
• Create/revise and implement department SOPs, work instructions and Safety Management Plans (SMPs)
• Develop and deliver training for safety related topics for internal personnel and external vendors
• Perform in line and/or end of line quality review 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

Preferred Qualifications

• 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 to meet patient and corporate needs
• Experience in both clinical required, 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

Benefits

• This position may be remote within the United States or hybrid on-site role in Redwood City, CA
• The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900