EU QPPV (remote-based)

Hobson Prior are seeking a EU QPPV to join a CRO who are focused on providing specialised services to the biopharmaceutical industry. This role will be remote based across the EU and on a permanent basis.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will deliver oversight over the functioning of the PV system in all related aspects. Manage development and implementation of standard procedural documents and processes.
• You will contribute as a standing team member in the preparation an approval of aggregate reports, Risk Management Plans, providing medical input to risk minimisation measures, RMPs and aggregate reports.
• Establishing and maintaining pharmacovigilance system, including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities.
• You will be managing the safety profiles of company's marketed products and any emerging safety concerns.
• To be the point of contact for the EMA and EU Competent Authorities on a 24-hour basis, and the contact point for inspections.
• You will be ensuring and verifying that the pharmacovigilance system master file is constantly an accurate and up-to-date reflection of that safety system.
• Contribute to the establishment and maintenance of Pharmacovigilance System, which ensures that information about all suspected adverse reactions which are reported to the personnel of the Company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community.
• To offer input into the preparation of regulatory action in response to emerging safety concerns. For requests from Competent Authorities, the EU QPPV will collaborate with the Company colleagues on the response strategy, development and approval.
• Review and approve including sign-off of protocols of post-authorisation safety studies conducted in the European Union or pursuant to a RMP agreed to in the EU.
• You will ensure full and prompt response to any request from Competent Authorities for the provision of information necessary for the benefit-risk evaluation of the products in collaboration with relevant departments.
• You will confirm that the conduct of PV and submission of all PV-related documents is in agreement with legal requirements and Good Pharmacovigilance Practice.
• To endorse, maintain, and improve compliance with PV legal requirements and maintain up-to-date knowledge of current PV regulations.
• Any other assigned duties.

Key Skills:

• Strong operational and managerial skills as demonstrated by leading previous projects or functions.
• Strong oral and written English communication skills.
• Common using Word, Excel, Power Point, Internet.

Requirements:

• Expert in PV system operations and function.
• Educated in M.D. or basic medical training or other education.
• Demonstrated as Deputy EU QPPV.
• Excellent knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in post-marketing.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.