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Deputy EU QPPV
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a Deputy EU QPPV for a large global pharmaceutical company, to be based in Amsterdam on a permanent basis. The Deputy EU QPPV performs per delegation the operative duties of QPPV as described in EU legislation to ensure compliant implementation and maintenance of the pharmacovigilance related regulatory requirements for company products Supports the European Union Qualified Person for Pharmacovigilance(EU-QPPV) in the management of office systems and procedures to ensure full compliance with European regulations, including Guidelines on Good Pharmacovigilance Practices (GVP) and international regulations
Performs per delegation the operative duties of QPPV as described in EU legislation to ensure compliant implementation and maintenance of the pharmacovigilance related regulatory requirements for company products. Supports the European Union Qualified Person for Pharmacovigilance (EU-QPPV) in the management of office systems and procedures to ensure full compliance with European regulations, including Guidelines on Good Pharmacovigilance Practices (GVP) and international regulations.
Job Responsibilities:
- Is the back-up for the EUQPPV in her/his absence and therefore bound to the same level of information and responsibilities
- Is the primary company contact for EMA and EU country agencies, in the absence of the QPPV on a 24/7 basis
- Develop and maintain at all times a complaint Pharmacovigilance System Masterfile (PSMF) and Pharmacovigilance System Summary and coordinates of the maintenance of the appendices from various contributors
- Ensures appropriate processes, resources, communication mechanism and access to all sources of relevant information required by the EU-QPPV
- Establishment and maintenance of EU-QPPV Office as key interface within company (across all relevant functions);
- Review of EU-QPPV system oversight tools, including all system compliance information received highlighting non-compliance to EU- QPPV
- Facilitates review, signature (if required) and proper archiving of all EU-QPPV Office outputs to enable rapid access at all times
- Maintains Pharmacovigilance registration details of EU-QPPV, Deputy and all other Users
- Supports all pharmacovigilance inspection interactions with EMA/ EU-EEA competent Authorities to facilitate timely submission of required documentation and completion of corrective actions, in collaboration with PVO,Clinical Quality Assurance(CQA) and EU- QPPV; Coordinates activities for pharmacovigilance inspections which are conducted in the EU in close cooperation with the EU QPPV and CQA
Skills and Requirements:
- BSc or other scientific degree plus further Master's degree Advantage: Relevant postgraduate qualifications in PV or GVPs
- Significant PV experience in the pharmaceutical or CRO
- Experience in Pharmacovigilance preferably gained in a European environment within drug safety department or QA;
- Exposure to at least 1 product submitted to Regulatory Authorities for marketing authorization in the EU
- Expert in the Safety Regulations and requirements relating to Pharmacovigilance in Europe
- Experience in Pharmacovigilance systems and Eudravigilance registrations
- Strong communicator with excellent English language skills, both written and spoken
- Good networking and team skills for successful cooperation with internal and external customers
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 Kevin Hansberry on +44 203 7520 314 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.
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