Senior Medical Director
hace 1 mes
About the Role
The Senior Medical Director will provide leadership and direction to the Safety Medical Sciences business functions and other assigned business functions, as well as providing strategic inputs to Safety Services Leadership. This role requires extensive experience and involvement in Pharmacovigilance / Drug Safety, with previous team management experience and the potential to grow into a bigger leadership role.
Key Responsibilities
- Represent the function/department at various internal and external forums.
- Contribute significantly to thought leadership activities.
- Responsible for resource management, overall quality, business continuity, utilization, and profitability.
- Maintain an excellent knowledge of the adverse event/safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines.
- Maintain an excellent awareness of global regulatory requirements, reporting obligations, and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
- Attend, provide consultations, and/or present at client/cross-functional meetings along with other stakeholders.
- Overall responsible for the quality of the function and function's Key Performance Indicators (KPIs) targets.
- Work in collaboration with the Safety Services Leadership Team and provide strategic and competitive inputs to the department and organization.
- Perform medical review of cases not limited to (including non-serious and serious spontaneous, clinical trial, and literature cases including combination products drug-device) according to client/Parexel Standard Operating Procedures (SOPs) as applicable and liaising with the client, as required.
- Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assess company causality.
- Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, and review narrative.
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