Senior Medical Director

hace 2 meses


Alcobendas, España Parexel A tiempo completo

.When our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values: Patients First, Quality, Respect, Empowerment & Accountability.We are looking for a Senior Medical Director with extensive experience and involvement in Pharmacovigilance / Drug Safety. This is a newly created role for the EMEA region and requires previous team management experience along with the potential and desire to grow into a bigger leadership role.Job PurposeThe Senior Medical Director is responsible for providing 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. The Senior Medical Director is also responsible for the implementation of suitable technology and innovations for the function and acts as Business Owner of related systems and Process Owner for applicable SOPs.Key ResponsibilitiesRepresent 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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