EU QPPV

A leading pharmaceutical client is searching for an EU QPPV to join their team in Germany. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

Job Responsibilties:

• As assigned by the Global Safety Board Chair, to act as General Safety Officer (GSO) to proactively manage the global safety aspects for a specific product, or group of products, as defined in company policies and SOPs.
• To be a member of the Global Safety Board - the body which reviews and makes decisions on drug safety issues for products globally for the company
• Contribute to/lead signal management (detection and evaluation) activities for specified products
• Contribute to/lead the responses to safety-related medical queries from regulatory authorities, external bodies and internally for specified products
• Provide safety expertise to the international project team for assigned products
• Contribute to the production and maintenance of Risk Management Plans and Risk Minimization Activities as required
• Contribute to/lead the production and amendment of safety information, including product labelling for specified products.
• Contribute to/lead the safety related aspects of the design and running of clinical studies, including involvement in the protocol production, investigators brochure production, support to the study team, monitoring of safety signals and involvement in the production of the clinical study report.
• To establish and maintain a high level of familiarity with the EU and international pharmacovigilance regulations and guidance relating to drug safety and pharmacovigilance and act as a point of reference for others.
• To act as EU Qualified Person for Pharmacovigilance (QPPV) according to the prevailing EU legislation and associated guidance and as defined in the company's SOPs.
• To approve all changes to the pharmacovigilance system as it applies to products authorised in the EU.
• To review and approve all protocols for PASS studies conducted with products authorised in EU
• To review and approve all EU RMPs and PSURs for products authorised in the EU

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 Herman Baer on + 41 78 679 7787 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.