Qualified Person Responsible for Pharmacovigilance QPPV in the EU and UK homebased
Qualified Person Responsible for Pharmacovigilance QPPV in the EU and UK homebased
Posted on :
20-12-2024
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1 Vacancy
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Job Description
The EU QPPV is responsible for:
- The establishment and maintenance of a 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;
- Ensuring that any request from the CAs for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a medicinal product is answered fully and promptly;
- Provision to the CAs of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product including appropriate information on planned postauthorisation safety studies.
- Being continuously available to CAs in Member States and the Agency and the MAH ensuring adequate backup procedures are in place.
- Having an oversight of the safety aspects of the companys medicinal products including an overview of medicinal product safety profiles any emerging safety concerns any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products and other relevant finding raised from studies/programmes conducted by the Company.
Qualifications :
- Lifescience education background Medicine (human or veterinary) or Pharmacy preferred
- Solid knowledge of PV system operations and function
- Strong knowledge of Global Regulations standards and best practices regarding safety processing and reporting safety surveillance and pharmaceutical industry compliance activities in postmarketing
- Strong operational and managerial skills as demonstrated by leading previous projects or functions
- Strong experience in a PV role profound experience as QPPV
- Strong oral and written English communication skills
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Key Skills
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