EU QPPV

Proclinical are partnering with a rare disease biotech company who are seeking a EU QPPV for their site in Dublin.

This role fulfills the responsibilities associated with the EU QPPV role and represents the company at European Regulatory agencies where required and appropriate.

More specifically, the EU QPPV is responsible for oversight of the pharmacovigilance system for all of company's medicinal products. This includes, but may not be limited to, ensuring that the company has an appropriate pharmacovigilance system in place; conducting review(s) of the safety profile for marketed products and acting as the point of contact with the appropriate regulatory/competent authorities as required and appropriate.

The EU QPPV provides oversight for the quality and standards of the PV function in order to ensure full compliance with EU/European Economic Area (EEA) PV regulations. This includes developing new, or revising existing Standard Operating Procedures (SOPs)/processes.

Job Responsibitlies:

• 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 company PV is in full compliance with EEA PV legislation, regulations, and guidance.
• Reviews Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post Authorization 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
• Contributes to Safety Data Exchange Agreements (SDEAs) and/or PV agreements with partners and/or vendors for EU/EEA-specific obligations for safety data exchange and reporting.
• 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.
• Contributes to inspection readiness and leads EU Health Authority inspections of the company's PV function.
• Participates in process improvement and vendor-client Safety Management Plans and timelines processing and reporting safety data from clinical trials and post-marketing surveillance.
• Trains internal stakeholders on EU PV regulations and requirements as required.
• Performs other tasks and assignments as needed and specified by management.

Skills and Requirements

• 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.
• Experience in writing SOPs and developing processes.
• Demonstrated knowledge of PV-related regulatory requirements in regions including North America, Latin America, Asia, Middle East, Australia, etc.
• Experience handling inspections and audits and CAPA.
• Critical thinking and decision making skills.
• Experience leading and contributing to inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management, etc.
• Demonstrated, hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alex Czuprynski on +44 203 8692 328 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.