QPPV - Pharmacovigilance Manager

29 Sep 2016
29 Oct 2016
Suki Chima
Contract Type
Full Time

I am currently recruiting for a client of mine based in the North West on a CONTRACT basis for a QPPV - Pharmacovigilance Manager.

The position will be responsible for establishing and maintaining the Market Authorisation Holder's Pharmacovigilance System - overseeing all safety profiles of the companies marketed products in the EU.

Job Details:

At present the Pharmacovigilance activities are contracted out to a service provider so the role will initially involve the setting up of the in house PV system and team. They will then be responsible for handling the transfer of material from the contractor to the in house system.

Having an oversight of the PV system and delegates tasks and maintaining ultimate responsibility on them, including:

  • Oversight on Individual case safety reports (ICSRs),
  • Standards Operating Procedures (SOPs),
  • Periodic Safety Update Reports (PSURs),
  • Risk Management Plans (RMP),
  • Risk Minimisation Strategies, effectiveness of follow-up measures, of post-marketing commitments, on safety database, on e-transmission and on important observations from QA audits of PV activities

Keep up to date about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology

Ensure full compliance of the MAH's PV system with the European regulations

Lead the preparation of aggregate safety reports (PSURs, DSURs, RMPs, safety issue workups etc), thus contributing to high quality standard documents within the organization

Desired Requirements:

Strong experience in pharmacovigilance (8+ years) in Pharmaceutical Companies, Biotech or CRO

Excellent knowledge of EU pharmacovigilance regulation and legislation

Medically qualified Doctor preferred but not essential

Strong expertise in medical safety writing

Experience in writing SOPs

Contract Length: 12 Months

Location: North West

Start Date: ASAP

Rate: Negotiable

If this role is of interest to you then please send an updated version of your CV and i will be in touch.

Alternatively if you know anyone who maybe interested then please pass this on.

To find out more about Huxley Engineering, please visit www.huxleyengineering.com

Huxley, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales