ProClinical is seeking an EU QPPV Office Safety Physician for a pharmaceutical company, to be based in Germany on a permanent basis. The EU QPPV Office Safety Physician reports to the EU Qualified Person for Pharmacovigilance (EU QPPV), thereby providing support to the QPPV in undertaking his / her responsibilities. He or she acts as the deputy for the EU QPPV.
The person will support the QPPV in making decisions and recommendations to ensure MAHs in Europe are compliant with the requirements of EU PV Legislation, and in ensuring that the company has appropriate systems for pharmacovigilance compliance and product safety management globally.
The person will work collaboratively with other departments (such as all other functions in Pharmacovigilance, Regulatory Affairs, Quality Management and Quality Assurance) within the company to address and resolve issues relating to products and PV processes.
The person will provide guidance to key stakeholders in addressing issues related to the PV System.
- Back-up to the EU QPPV
- Maintain an awareness of developments in the safety profiles of the company products and have an up-to-date overview of status of the safety profiles and emerging safety concerns
- Review of key regulatory documents and programs, such as PSURs, RMPs, PASS and CAPAs, prior to approval by the EU QPPV.
- Co-drive continuous improvement of the PV system and its performance
- Contribute to the maintenance of the PSMF
- Act as a contact point to the EU QPPV for all pharmacovigilance matters and safety governance issues, including audits and inspections, for products globally
- Participate in internal and external groups for networking, intelligence gathering and input, as agreed with the EU QPPV
- Act as ambassador for PV governance within and outside the company
- Engage with the relevant functions in the development and review of key regulatory documents related to PV for company products
- Stay abreast on the local PV system in the region in terms of organization and performance
Skills and Requirements:
- MD Physician
- At least 3 years of experience in pharmacovigilance
- Training in EU PV legislation requirements and GVP
- Familiarity with global pharmacovigilance requirements
- Strong working knowledge of relevant Pharmacovigilance legislation and regulations
- Good understanding of medical practices and health systems in Europe
- Experience in Pharmacovigilance preferably as deputy EU-QPPV or as a therapeutic area lead or safety physician at a global level
- Excellent verbal and writing skills in English with experience writing, editing and compiling regulatory experience
- Understanding of the processes associated with Safety, Regulatory, and Clinical Development in the context of a multinational pharmaceutical company
- Good understanding of PV operational aspects both at a local and at a global level
- Demonstrated ability to lead projects, teams, initiatives, or programs across multiple departments, regions and business units and external stakeholders
- Experience providing deliverables for health authorities (including but not limited to the US FDA, EMA, MHRA) is preferred
- Experience with typical tools used in Pharmacovigilance for example CAPA management system, safety database etc.
- Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, PowerPoint, Visio, etc.)
- Excellent communication and organisational skills, adherence to timelines and the ability to deal with multiple tasks at the same time.
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 Kevin Hansberry on +44 207 4400 636 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.