Drug Safety Case Manager

Role:
Drug Safety Case Manager supporting Cytokinetics' pharmacovigilance operations within a specialty cardiovascular biopharma.

• processing safety reports in compliance with ICH-GCP and regulatory standards
• overseeing CRO activities related to SAE processing
• maintaining safety databases
• preparing safety reports
• ensuring departmental compliance
• study start-up activities
• cross-functional collaboration
• process improvement
• training
• regulatory adherence

• Degree in life sciences
• 3-5 years' drug safety experience covering ICSR and periodic reporting
• familiarity with domestic and international PV regulations
• experience with Argus or ARISg databases
• strong MedDRA and WHODRUG coding skills
• proficient in MS Office
• excellent communication and organizational skills
• ability to work independently in a dynamic environment

Preferred: healthcare professional background (pharmacy, nursing).

High-Value: focus on pharmacovigilance for cardiovascular therapeutics, with emphasis on safety data analysis, regulatory reporting, and cross-departmental collaboration.

Work setup: location in South San Francisco, CA, with a competitive salary range, comprehensive benefits, and a focus on integrity and patient-centered actions.