Job Description
This is a rare opportunity to join one of the most exciting young global biopharmaceutical companies, headquartered here in Dublin. With a rich development and commercial pipeline our client is focussed on rare and orphan diseases.
Reporting to the Chief Medical Officer, the Head of Pharmacovigilance (PV) and Drug Safety will lead a team to optimize patient benefit and minimize risks related to exposure to the company’s products through robust safety evaluation expertise and medical innovation. This role is responsible for ensuring optimal patient safety as first priority by developing a state-of-the-art safety strategy, driving medical safety processes and capabilities and having accountability for safety compliance. The Head of PV and Drug Safety responsible for building an efficient team and attracting, retaining and developing talent.
Job Spec
- Manages an efficient and successful medical safety organization, which provides robust medical and science-driven contribution to risk-benefit evaluation throughout product lifecycle to enable our client to provide impactful therapies to patients worldwide.
- Enhances scientific and clinical experience of staff through continuous training and coaching. Participates in building the talent pipeline for key roles in Medical Safety. Responsible for attracting, retaining and developing talent within the PV organization.
- Prepares safety objectives and evaluates and manages performance of the PV team.
- Accountable for the delivery of high quality, timely and standardized medical safety deliverables. Provides content guidance and functional approval, as needed, for all safety documentation.
- Establishes and maintains common global processes and guidelines for medical safety assessment, analysis, and compliance, including documented guidance for coding and the assessment of causality/expectedness for adverse event reports, as required.
- Ensures that medical safety signals from aggregate data are identified promptly and communicated/escalated appropriately, including oversight (as appropriate) of use of signal detection tools and other sources for potential product signals.
- Maintains a close collaboration with global associates by proactively escalating potential safety issues / changes that affect the risk-benefit profile of company products. Reviews PSURs and RMPs as a delegated activity, when required. Leads and/or coordinates as appropriate the preparation of medical stewardship data/information for the company, crisis management teams, and Health Authorities.
- Design, implement and manage Risk Evaluation and Mitigation Strategies (REMS) in order to ensure that benefits outweigh potential risks.
- Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues from other functions, e.g. Clinical Development, Medical Affairs, Regulatory Affairs, Medical Information, and QA, as well as externally with expert panels and other scientific contacts.
- Communicates effectively and efficiently on safety and benefit risk issues to internal and external groups.
- Contributes to and provides medical pharmacovigilance review of Company Core Data Sheets, patient information leaflets and summary of product characteristics.
- Act as a core member of the Labelling Review Committee and advises management on safety items which may impact labelling worldwide.
- Act as a core member of the SRC/GRC ensuring that requests for the company to support Investigator Initiated Studies are evaluated, approved, implemented, and managed in a manner that ensure compliance with applicable regulatory requirements.
- Act as a bridge between PV Ops and Clinical Safety to ensure on-time delivery of safety related sections of the product dossier.
- Coordinate and monitor any budget or contract negotiations with the PV vendors.
- Manages the PV global departmental budget. Draw up yearly budget in collaboration with Finance Department for all PV activities.
- Review the organisation's objectives and targets and the impact on the budget.
- Oversight of safety Vendors.
- Participate in global regulatory inspections as a SME for specific PV topics and processes.
- Ensuring all critical and major GVP non-compliance issues are put through the CAPA process.
- All safety CAPAs for audit/ and/or inspection findings & deviations are closed by the due dates.
- Medical degree required. Specialty Board Certification desirable. Useful additional degrees: Post-graduate degree in Pharmaceutical Medicine; Master of Public Health (or equivalent) would be an advantage.
- A minimum 5 years of postdoctoral clinical experience required.
- At least 10 years in drug development in a major pharmaceutical company, including a minimum of 7 years in a safety-related position.
- Global Pharmacovigilance experience is strongly desired.
- Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.
- Experience in responsible/leading roles in clinical or safety through complete submission process.
- Experience in presenting clinical or safety data to major health authorities.
- Strong leadership skills including coaching, motivating, and directing, and fostering teamwork.
- Ability to develop and maintain effective working relationships with subordinates, superiors and peers.
- Strong negotiation and conflict management skills.
- Experience in leading cross-functional, multi-cultural teams.
- Experience in drug development, clinical trial methodology.