Deputy EEA QPPV
The Opportunity
We are seeking an experienced Deputy EEA Qualified Person Responsible for Pharmacovigilance (QPPV) to support the QPPV Office and help ensure ongoing compliance with global and European pharmacovigilance legislation and regulatory requirements.
Reporting directly to the QPPV, you will act as a key scientific and operational partner, providing expert pharmacovigilance input across safety surveillance, risk management, aggregate reporting, regulatory activities, inspections and governance. The role will also act as a back-up to the QPPV, assuming QPPV responsibilities during periods of absence.
Key Responsibilities
- Act as the Deputy QPPV and back-up QPPV when the QPPV is absent.
- Support the QPPV Office in maintaining a robust and compliant global and European pharmacovigilance system.
- Ensure awareness and compliance with PV requirements, including the quality and timely submission of individual case reports and aggregate reports, as well as implementation of risk minimisation activities.
- Review and provide scientific input into EU RMPs, PSURs/PBRERs, DSURs, PADERs and other relevant safety documentation.
- Support review of labelling updates, clinical overviews, scientific documents and pharmacovigilance procedures.
- Review and provide input into Safety Data Exchange Agreements (SDEAs) and MSAs where applicable.
- Participate in Signal Management activities, contributing to the identification and evaluation of safety signals from available sources.
- Provide medically qualified support to the QPPV where required.
- Represent the QPPV in Safety Management Team, Medical Review Group and other relevant meetings as assigned.
- Participate in NTM review and approval and support development and dissemination of QPPV notifications and other important safety information.
- Contribute to development and maintenance of product safety profiles and provide advice on safety issues and regulatory authority requests.
- Review and provide scientific input into PASS and PAES protocols, amendments, final study reports and publications.
- Ensure prompt and complete responses to requests from competent authorities and the EMA relating to the benefit-risk evaluation of medicinal products.
- Review and provide scientific input into variations, renewals, SmPCs, DHPCs, Investigator Letters, response documents, educational materials and health hazard evaluations.
- Contribute to oversight and control of the pharmacovigilance system, including compliance with processes and system requirements.
- Support internal and external audits and regulatory inspections relating to the QPPV Office.
- Ensure relevant product safety information and safety profile updates are communicated to the QPPV in a timely manner.
- Support the development and maintenance of key procedural documents, including SOPs, IPVCDs and Working Instructions relating to QPPV responsibilities.
- Support QPPV PRAC activities and Scientific Advice participation.
- Represent the QPPV in MRG, SMT and other relevant forums covering signal assessment, risk management, aggregate analysis, epidemiology, signal detection and aggregate reporting approaches.
- Act as Global Process Owner for the Important and Urgent Safety Concern (IUSC) process.
- Collaborate with Quality, EEA QP Batch Release, Regulatory, Clinical Development and Medical Affairs functions.
- Chair or co-chair the QPPV Safety Forum, supporting scientific exchange and benefit-risk updates across products.
- Act as an ambassador for pharmacovigilance governance both within and outside the organisation.
About You
The successful candidate will have:
- An MD or international equivalent, PharmD or PhD, combined with considerable pharmaceutical industry experience in Pharmacovigilance.
- 10+ years of pharmaceutical industry experience, typically including at least 5 years working in Pharmacovigilance in local and regional roles.
- Experience in Regulatory Science and regulatory supervisory agency inspections within the EEA.
- Strong expertise in Pharmacovigilance and excellent knowledge of global and EEA PV regulatory obligations.
- Subject matter expertise in EEA and relevant international legislation and guidance, including ICH and CIOMS.
- Strong experience with RMPs, PSURs/PBRERs, DSURs and US periodic data presentations and interpretation requirements.
- Excellent organisational, facilitation, interpersonal and communication skills, with the ability to work effectively across multidisciplinary, local, regional and global teams.
- Strong decision-making and problem-solving capabilities, particularly when addressing complex safety issues and balancing operational and strategic requirements.
- The ability to independently manage multiple projects and tasks, follow up on outstanding issues and drive effective resolutions.
- Strong scientific judgement and the ability to negotiate complex or challenging safety issues creatively and effectively.
- The ability to recognise broader process and environmental implications of safety decisions and appropriately consult or escalate issues to the QPPV.
- A proactive approach to shaping and strengthening Pharmacovigilance within the QPPV Office.
