European QPPV London

Permanent / London, UK

Up to

European QPPV- London - Up to £130,000

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:

You will undertake the duties of the EU Qualified Person including;

• Pre- and Post-Market safety cases medical assessment
• Case narrative review
• MedDRA coding
• Interactions with the necessary Regulatory Authorities
• Risk Management Plans
• Pharmacovigilance System Master File's preparation
• Periodic Safety Report review
• Provide medical expertise on assigned projects where needed
• Represent the business at relevant conferences within Europe to support business growth

Experience

• You will need to have experience in Pharmacovigilance at a senior level and also have experience in a QPPV role.
• Medically qualified Doctor
• 8 years experience within pharmacovigilance working with either a Pharmaceutical, Consultancy or Biotech business
• Experience in writing RMPs
• Expert knowledge of EU pharmacovigilance regulations
• Experience in writing SOPs
• Knowledge of regulatory requirements in other regulatory regions including the USA or Asia
• Experience handling inspections and audits

 

Keywords: QPPV, Pharmacovigilance, EU, London, Qualified Person, Medical Sector, Global Pharma, Consultancy, Biotech, EUQPPV, EEA, Europe, QP, Physician, Medical Doctor, MD,

 

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.