Director of Pharmacovigilance – EU QPPV
This leading pharmaceutical innovator is an organisation focussed on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. While this organisations discovery programs are directed at targets in multiple therapeutic areas, they are focusing particularly on the development and commercialisation of treatments for orphan and ultra-orphan disorders. With a number of products on the commercial market and an extremely healthy product pipeline which addresses multiple therapeutic areas, including neuromuscular disorders, oncology and infectious diseases, the future of this organisation looks bright. Due to further expansion here in Ireland, a new requirement has arisen for a Director of Pharmacovigilance – EU QPPV to be based at the organisation new EU HQ here in Dublin.
- Fulfills all regulated responsibilities of the EU Qualified Person for Pharmacovigilance.
- As per PV regulations in the EU, acts as the single PV contact point for the EU competent authorities in Member States and the Agency on a 24-hour basis and is also as a contact point for PV inspections.
- Ensures PV is in full compliance with EEA PV legislation, regulations, and guidance.
- Reviews Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post Authorisation safety study (PASS) protocols and approves as needed per EU requirement(s).
- Oversees and supports all local safety officers/local QPPVs in EU/EEA region by maintaining an open line of communication and through monthly and quarterly meetings.
- Supports market expansion in Europe and collaborates with local operating company’s key stakeholders.
- Key contributor to the company’s adherence to the PV quality system, SOPs and processes. Ensures compliance with PV-related regulations within the region.
- Responsible for the development and delivery of Pharmacovigilance System Master File (PSMF) updates.
- Oversees medicinal product safety profiles and any emerging safety concerns; maintains awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products and maintains awareness of risk minimization measures.
- Ensures quality, including the correctness and completeness of PV data submitted to the competent authorities in Members States and the Agency.
- Provides input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
- Provides medical review of Adverse Event (AE) cases as a back up to the Safety physician
- Works closely and collaborates with department head and PV physician to develop, and actively contribute to, processes for medical surveillance plan, aggregate report compilation, RMPs, etc.
- Builds relationships, and collaborates with, the Quality department to ensure appropriate processes are in place for inspection readiness. This includes, but may not be limited to, leading pharmacovigilance audit responses, developing and managing corrective action plans, etc.
- Participates in process improvement and vendor-client Safety Management Plans and timelines processing and reporting safety data from clinical trials and post-marketing surveillance.
- Medical degree (Medically qualified Physician) and a minimum of 8 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment as an EU QPPV or Deputy QPPV.
- Expert knowledge of European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
To learn more apply online or contact Shane Browne at HRM on +353 1 632 1865.
Salary: On Application
Location: Dublin City Centre