Sr Manager Drug Safety Operations

Technical Responsibilities include but are not limited to:

• Process and evaluate Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of 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. Develop study-specific and program-level safety management plans using templates from CRO. Create, review, and update drug safety forms and templates to align with relevant clinical operation documents (e.g., SAE data collection forms and CRFs).
• 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. Lead cross-functional projects, gather input, and achieve consensus on safety operational topics.
• Develop and/or update Standard Operating Procedures (SOPs), processes, and practices for study lead and SAE case processing activities, in compliance with drug safety and pharmacovigilance regulations and standards.
• Manage and execute personal work effectively to achieve departmental goals.
• Additional duties and responsibilities as assigned.

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