Senior Medical Director - Pharmacovigilance/Drug Safety Lazio

Senior Medical Director - Pharmacovigilance/Drug Safety
Roma
Lazio, Lazio

Senior Medical Director - Pharmacovigilance/Drug Safety PAREXEL When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. 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 Purpose The Senior Medical Director is responsible for providing leadership and directions to the Safety Medical Sciences business functions and other assigned business functions, as well as provide strategic inputs to Safety Services Leadership. Key Accountabilities Maintaining 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. Maintaining an excellent awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting. Attending, providing consultations and/or presenting at client/cross functional meetings along with other stakeholders. Overall responsible for quality of the function and function's Key Performance Indicators (KPIs) targets. Performing medical review of cases not limited to (including non-serious and serious spontaneous (including legal cases), clinical trial, and literature cases including combination products) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as required. Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assessing company causality. Reviewing and/or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs. Providing input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs). Performing signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Contributing to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues. Preparing and reviewing periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs. Knowledge and Experience Extensive drug safety and clinical trial knowledge and experience. Clinical practice experience. Managerial and Leadership experience a must. Very strong knowledge/understanding of medical terminology. Education Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School. Completion of at least a basic training in clinical medicine (residency, internship etc. ) Summary Location: United Kingdom-Uxbridge-Remote; Croatia-Remote; Hungary-Remote; Czech Republic-Remote; Lithuania-Remote; Spain-Remote; South Africa-Bloemfontein-Remote; Turkey-Remote; Italy-Remote; Poland-Remote; Romania-Remote; Israel-Remote; Serbia-Remote; Ireland-Remote Type: Full time J-18808-Ljbffr