EU Qualified Person Responsible For Pharmacovigilance (QPPV)

EU Qualified Person Responsible For Pharmacovigilance (QPPV)

JOB TITLE:

EU Qualified Person Responsible For Pharmacovigilance (QPPV)

JOB SUMMARY:
We’re offering a great opportunity for an experienced EU QPPV candidate to join our client’s global Regulatory and Safety Services Consultancy!

Our client is currently the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services.
Their services are targeting support for comprehensive compliance and safety throughout the product lifecycle for their clients, therefore enabling continuity and productivity of product development and subsequent processes.

The company culture has a great family feel and real positive atmosphere within their working environment. Their staff are highly passionate about patient safety and service quality, and they have built a highly experienced and supportive team. If you enjoy being a part of a multicultural, multidisciplinary, and customer focused company, and you enjoy leading different global projects then this could be an ideal opportunity for you.

Full training will be provided and staff are encouraged to attend external courses as appropriate and to join professional organisations. There will be opportunities for advancement within the company or the wider group for motivated candidates, who have the ambition and potential for growth in our client’s dynamic and international organisation.

Job Title EU Qualified Person Responsible For Pharmacovigilance (QPPV)
Location Applicants can be based at any EU member state (must be EU resident)
Salary (Basic) £80,000 per annum, plus benefits package
Primary Responsibilities:
  • Overseeing the preparation/validation for the competent authorities of the EU member states of all safety related reports and documents
  • Ensuring that the benefit risk assessment of the products are current to ensure the continuous monitoring of patient safety and that changes to the assessments are followed by appropriate actions
  • Ensuring that full and appropriate responses are provided to any national competent authorities and to the European Medical Agency
  • Ensuring and verifying that the Pharmacovigilance System Master File is up-to-date and fit for purpose
  • Contact point for audit and inspection and with the EMEA (24/7)
  • Act when issues are escalated on a 24 hour basis
Candidate Profile:
Experience Required 5-7 years minimum experience in Pharmacovigilance and as a European QPPV
Education & Qualifications The minimum educational requirements are a Life Science degree (BSc, MSc, and/or PhD). Applicants with an MD are preferred. If based in France you will need to be a qualified Pharmacist or a Physician.

For information on the minimum requirements for each member EU state for the QPPV role, please read the following:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/02/WC500221474.pdf

Core Competencies Project management skills
Rigorous and pragmatic
Customer and Quality focus
Result driven
Problem solving capabilities
Team spirit
Key Skills Required:
  • Excellent knowledge of PV regulations and guidelines (GVP)
  • Resident in EU
  • Experience and knowledge of local QPPV responsibilities
  • Knowledge in medical writing/reviewing aggregate reports and RMP, signal detection management
  • Medical (MD) qualification desirable
  • Compliance focus
  • Fluent in English (spoken and written) for daily contacts with local and international partners.
The company culture has a great family feel and real positive atmosphere within their working environment. Their staff are highly passionate about patient safety and service quality, and they have built a highly experienced and supportive team.

Contact us to learn more about this great opportunity!

Key Contact:
For more information about this vacancy and to discuss further please contact Dan Johnston at djohnston@hearttalent.com or use the application form near the top right-hand side of this page.

APPLY HERE!

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