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EU QPPV ITALY

Permanent / Italy

up to

European QPPV - Italy - Office Based

Our Client is a specialist consultancy that works with start-ups to mid-size companies to bring products to the market in the most efficient and cost-effective manner.

The company assists pharmaceutical, medical technology and biotechnology companies in the design and implementation global regulatory strategies to ensure compliance and a smooth entrance to market and beyond

The Job:

You will have oversight of the PV systems in terms of structure and performance, case processing and medical review including QC and QA procedures.

Requirements:

The EU QPPV will perform the following activities on behalf of the Marketing Authorization Holder.

Responsibilities will include:

  • Oversight of the PV system.
  • Acts as a main PV contact point for the regulatory authorities and the European Medicine Agency
  • Ensure that the Marketing Authorization Holder has appropriate PV system in place.
  • Oversees functioning of PV systems in all relevant aspects including its quality systems including
  • SOPs,
  • Training,
  • Contractual arrangements,
  • Database operations,
  • Compliance data regarding quality,
  • Audit/inspection reports
  • Ensuring that all PV processes conducted throughout the EU are in accordance with pertinent regulations
  • Oversees preparation and maintenance of PV System Master File
  • Maintains an overview of safety profiles and any emerging safety concerns of all Marketing Authorization Holder products
  • Review and sign off of Risk Management Plans.
  • Ensures that the signal management process is in place in order to identify possible safety signals on Marketing Authorization Holder products
  • Ensures that the risk based audit of PV system is performed at pre-defined intervals

Experience

You will need to have experience in Pharmacovigilance at a senior level and also have experience in a QPPV role.

 

Keywords: Qualified Person, Pharmacovigilance, Italy, Drug Safety, European QPPV, Office Based, QPPV, EU, EEA, Medical Doctor, Physician

 

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.

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About us

Resourcing Life Science is a specialist recruitment agency, providing career advice and employment opportunities within the Pharmaceutical, Biotechnology, Medical Devices and Clinical Research industries across the globe.

Contact

info@life-science.co.uk

0044 (0) 207 421 0000

0049 152 1164 1635

Resourcing Life Science Ltd.
Clerkenwell Workshops,
27/31 Clerkenwell Close,
London
EC1R 0AT