Senior Medical Director

hace 1 mes

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 Purpose
The 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 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.
Review and/or author aggregate reports for medical content and consistency in accordance with client requirements and SOPs.
Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness.
Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities.
Author/review Serious Adverse Event Reports (SERs). Perform case analysis, review literature summaries, and check draft for medical and scientific accuracy and cohesiveness.
Author/review responses to Health Authority requests and other safety documents.
Manage safety signals on project-specific tools (e.g., Signal Tracking System, Signal management tools, etc.).
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues.
Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European Union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs.
Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels, and Development Core Safety Information (DSCI).
Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents.
Contribute to regulatory agency submissions (Investigational New Drug applications, New Drug applications, Marketing Authorization applications, Variations, and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages.
Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable.
Ensure alignment of Therapeutic Area objectives, safety strategies, and issue escalation with Pharmacovigilance.
Oversee continuous evaluation of safety and benefit-risk assessment activities and strategies for the Therapeutic Area.
Support other therapeutic area teams and deputize for the PV Head if required.

Knowledge and Experience:

Extensive drug safety and clinical trial knowledge and experience.
Clinical practice experience.
Managerial and Leadership experience is 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.).

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