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Senior Medical Director - Pharmacovigilance/Drug Safety
Client: Parexel
Location: Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: fedc5529e6ab
Job Views: 24
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:
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 directions 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 Accountabilities
1. 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.
2. 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.
3. Attending, providing consultations and/or presenting at client/cross-functional meetings along with other stakeholders. Working as Subject Matter Experts (SMEs).
4. Overall responsible for the quality of the function and function’s Key Performance Indicators (KPIs) targets.
5. Working in collaboration with Safety Services Leadership Team and providing strategic and competitive inputs to the department and organization.
6. 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 {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as required.
7. Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assessing company causality.
8. Reviewing and/or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs.
9. Reviewing and signing off adverse events reports for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness.
10. Providing input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
11. Performing signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Performing medical assessment of safety alerts obtained from data mining activities.
12. Authoring/reviewing Serious Adverse Event Reports (SERs). Performing case analysis, reviewing literature summaries, checking drafts for medical and scientific accuracy and cohesiveness.
13. Managing safety signals on project-specific tools (e.g., Signal Tracking System, Signal management tools, etc.).
14. Contributing to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues.
15. 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.
16. Providing safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents.
17. Contributing 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.
18. Participating in or providing input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable.
19. Managing Safety Officers, Signal Management Experts, Risk Management Experts, PV Scientists and administrative assistants.
20. Ensuring alignment of Therapeutic Area objectives, safety strategies and issue escalation with PV.
21. Overseeing continuous evaluation of safety and benefit risk assessment activities and strategies for the Therapeutic Area.
22. Supporting other therapeutic area teams and deputizing 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 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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