Drug Safety Case Manager

Role: Drug Safety Case Manager supporting Cytokinetics’ pharmacovigilance operations within a specialty cardiovascular biopharma. Responsibilities include processing safety reports in compliance with ICH-GCP and regulatory standards, overseeing CRO activities related to SAE processing, maintaining safety databases, preparing safety reports, and ensuring departmental compliance. Also involved in study start-up activities, cross-functional collaboration, process improvement, training, and regulatory adherence. Qualifications: 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.