Drug Safety Case Manager
Cytokinetics · South San Francisco, CA
SafetyFull-time$136k–$158kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Cytokinetics seeks a Drug Safety Case Manager to support pharmacovigilance operations, including processing safety reports, maintaining quality systems, and ensuring regulatory compliance for cardiovascular products. The role involves database management, case assessment, cross-functional coordination, and participation in clinical trial safety oversight.
What they're looking for
- Life sciences degree; pharmacy, nursing, or healthcare professional background strongly preferred
- 3-5 years drug safety experience with ICSR and periodic report exposure
- Knowledge of domestic and international drug safety regulations and industry standards
- Proficiency with drug safety databases such as Argus or ARISg
- Skilled in MedDRA and WHODRUG coding dictionaries
- Proficient with MS Word, Excel, PowerPoint, and Outlook
- Strong written and oral communication skills with attention to detail
What you'll be doing
- Process safety reports in database and ensure reporting compliance with ICH-GCP guidelines and regulatory requirements
- Review source documentation, assess case reportability, and conduct quality checks for adverse events
- Coordinate follow-up for missing safety data and reconcile SAE discrepancies between clinical and safety databases
- Prepare safety narratives for expedited and non-expedited reports and assist with regulatory submissions
- Support study startup activities including development of Safety Management Plans and site initiation training
Privacy & handoff
This role links to Cytokinetics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.