Director Remote Jobs: EU QPPV. A BioPharmaceutical company specialising in rare diseases are building a Global infrastructure of novel drugs with the potential to treat multiple diseases.
The Senior Director EU QPPV is responsible for establishing and maintaining a compliant pharmacovigilance system, in line with the European Directive and the EU GVP modules.
A member of the Global Drug Safety department, this role involves interacting with key stakeholder groups, oversight of the Global PV system, product review and approval, managing local safety officers and providing strategic improvements to the Global PV department.
Director Remote Jobs: EU QPPV. Key Responsibilities:
The EU QPPV is responsible for driving the following key specific areas through his/her own activity:
- Oversee preparation and execution of Pharmacovigilance agreements
- Oversee and be informed of ICSR processing and submissions
- Review and approve PSURs/PBRERs, RMPs, and Post-authorisation safety study protocols
- Keep key stakeholder groups informed of new safety regulations and guidance from the regulatory authorities in the EU
- Manage local safety officers from countries within EEA/other EU regions
- Point of safety contact for safety related needs and questions from EEA countries/other EU countries
- Participates in the signal management system with regular review of safety data for assigned products and detection and evaluation of new safety signals in conjunction with the Global Safety Lead
- Contributes to other Post-marketing Pharmacovigilance related matters as assigned
Director Remote Jobs: EU QPPV. Qualifications and Experience:
- M.D. with solid knowledge and clinical practice experience of General Medicine.
- Clinical Development and Postmarketing pharmacovigilance experience required.
- 10 + years of experience in the biotech/pharmaceutical industry
- At least 3 to 5 years of experience as EU QPPV in recent years
- Preferable: experience in Rare Diseases and Orphan Drugs
If you are interested, then please contact firstname.lastname@example.org or call on 07775 696425.
In a world of machine learning, big data, and artificial intelligence, ARTO puts people at the heart of recruitment in the life sciences.
We are inspired by technologies bringing new treatments, cures and drugs within human reach.
But with our expertise in drug safety and pharmacovigilance, we also know it is human talent that gets those cures to market and to the patients who need them most.
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