Drug Safety Operations Manager
7 days ago
Job Summary
">This is a pivotal role within EPM Scientific, responsible for overseeing operational activities related to drug safety studies from inception to completion. It involves monitoring clinical trial vendor activities and supporting key tasks related to case processing management in 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, including generating queries, MedDRA coding, and narrative writing.">
- Manage and implement a high standard of 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, and contributing to IND Annual Reports in collaboration with the Drug Safety Physician.">
- Create, review, and update drug safety forms and templates to align with relevant clinical operation documents.">
- Monitor the activities of CROs and partners to ensure compliance with applicable Safety Management Plans (SMPs), Pharmacovigilance Agreements (PVAs), and other contractual obligations.">
- Collaborate with Data Management to carry out SAE reconciliation activities per study-specific plans.">
- Train new safety staff on the Argus system and case processing.">
- Work with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure proper collection and management of safety data.">
Requirements:
">We are seeking an individual with a BS/BA degree in a related field and at least 9 years of relevant experience; or MS/MA degree in a related field with at least 7 years of relevant experience; or equivalent experience/understanding of study management. The ideal candidate will have experience in the biotech/pharmaceutical industry and/or oncology, familiarity with the Argus safety database, and experience in processing clinical trial and spontaneous adverse events.
">Estimated Salary Range:
">$120,000 - $180,000 per year, depending on qualifications and location.
EPM Scientific is an equal opportunities employer.
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