Clinical Safety Manager
3 weeks ago
Job Summary
This role is responsible for overseeing operational activities related to drug safety studies, from start-up to closeout. Key responsibilities include monitoring clinical trial safety vendor activities and supporting case processing management within the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations.
Responsibilities
- Process and evaluate Serious Adverse Events (SAEs) and Adverse Events (AEs) from receipt until case closure in the Argus database.
- Manage case quality review to ensure accurate medical safety data documentation with the support of the Drug Safety Physician.
- Perform Safety Study Lead tasks, such as reviewing Investigator Brochures and study protocols.
- Collaborate with Data Management to carry out SAE reconciliation activities per study-specific plans.
Requirements
- BS/BA degree in a related field with a minimum of 9 years of relevant experience; or MS/MA degree in a related field with at least 7 years of relevant experience.
- Experience in the biotech/pharmaceutical industry and/or oncology is preferred.
- Familiarity with the Argus safety database is preferred.
Salary Information
$110,000 - $140,000 per year, based on location and experience.
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