- Requisition ID: WD199584
- Position: Full-Time Regular
- Functional area: Medical and Clinical
- Location: Wavre, Wavre
ViiV Healthcare (VH) is a dynamic, independent company 100% focused on delivering new treatments to people living with HIV. Established in 2009 through a unique partnership between GSK and Pfizer, and Shionogi, who joined in 2012. At ViiV Healthcare we work in close partnership with GSK as the majority owned shareholder, in establishing and maintaining an effective Pharmacovigilance (PV) system.
This role offers the opportunity to work with VH EU QPPV based in Belgium and the VH global safety team at the headquarters of ViiV Healthcare based in London, UK, alongside a team of passionate individuals committed to delivering advances in HIV therapy. The VH global safety team is led by VH VP, Safety & PV working closely with the EU QPPV. The successful candidate will report to ViiV Helathcare VP, Safety & Pharmacovigilance.
The role is based in Wavre (Belgium)
The purpose of the position is to fulfil the role of VH EU Deputy QPPV working closely with VH EU QPPV and the VH global safety team in overseeing PV activities and optimizing VH Quality Management System
You will fulfill the role of Deputy QPPV and be a back-up for VH EU QPPV in accordance with European legislation. The Deputy QPPV is fully cognizant of all relevant PV regulation and internal PV processes and significant ongoing safety issues so that he/she can assume the responsibilities in the absence of the QPPV.
In conjunction with the VH Deputy Head of Safety you will manage the established VH “QPPV Office and PV Oversight Committee” including but not limited to collection and compilation of relevant metrics and information, chair meetings and track actions to completion.
You will also assist the VH global safety team in the creation and maintenance of relevant process documents to ensure optimum performance of VH PV system as well as assisting in production and updates of VH EU PSMF (PV System Master File).
The Deputy EU QPPV may also act as a delegate to EU QPPV and VH VP, Safety & PV in reviewing and signing off of safety related documents for ViiV Healthcare products (e.g. regulatory reports) under the direction of EU QPPV or VH VP, Safety & PV.
Higher Degree in a medically related discipline (Doctor of Medicine or equivalent)
• In-depth knowledge of drug safety with a minimum of 5 years’ experience in industry or a regulatory agency. Proven pharmacovigilance expertise and an in depth understanding of PV requirements, in particular the European regulations contained in legislation referred to as EU Pharmacovigilance Directive and GVP, together with sound judgment in addressing PV and product safety related issues.
• Innovative and practical approach to problems
• Good communication skills (including technical/clinical writing skills and verbal communication)
• Good IT skills including but not limited to Word, Excel, Outlook, SharePoint
• Excellent organisation skills and sense of urgency/working to tight timelines
• Attention to detail
• Ability to navigate complex projects and interact in a matrix environment
• Demonstrated ownership of projects and tasks
• Development and/or implementation of process improvement initiatives
• Have a flexible approach
• Confident in interacting with people in the organization
• Self-motivated, able to work both independently and in teams, and with the intellectual flexibility to continually develop and learn new skills
• Fluent in English language