Pharmacovigilance Manager- Deputy QPPV- London/Surrey

Recruiter
Meet Recruitment Ltd
Location
Surrey
Salary
£75,000
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time

Pharmacovigilance Manager- Deputy QPPV? London/Surrey - £70,000

We are a highly unique Global Biopharmaceutical company with offices based in the Surrey area and we are currently looking for a Pharmacovigilance manager/ Deputy QPPV.

You will have responsibility for the establishment, maintenance and operation of the PV system for the company. Working on Risk Management plans, PSUR preparation and implementation of signal detection procedures. This is a great role for someone looking to join a small, developing company where they can have visibility and responsibility across the company?s whole portfolio and in time have the opportunity to move into a QPPV role.

This position is being dealt with by Zoe Benningfield-Fox @Meet

Company Background

We are a Global Biopharmaceutical company with a focus on the development of dermatology drugs, treating serious rare skin disorders. They have a leading product (first-in-class dermatology drug) that has been granted marketing authorisation, and are looking to expand their presence across Europe through the development of a UK office.

This is a dynamic, ambitious company looking to become world leaders within the field of dermatology, continuing to develop and share knowledge on all aspects related to the severe skin disorders they strive to treat.

This position is being dealt with by Zoe Benningfield-Fox @Meet

Role Responsibilities

  • Establishment, maintenance and operation of PV system
  • Establish and follow a quality management system that is adequate and effective
  • Develop and maintain a description of the pharmacovigilance system (PSMF)
  • Maintain and update of the Risk Management Plan (EU)
  • Write SOPs and Working Practices
  • Prepare PSURs and Annual reports
  • Implement procedures for signal detection, evaluation and handling safety restrictions
  • Main interface with regulatory agencies
  • Manage company safety database

This position is being dealt with by Zoe Benningfield-Fox @Meet

Requirements:

  • Post Graduate Life Sciences Degree (Pharmacy / Medical)
  • Extensive experience, qualifications in Pharmacovigilance (5+ years? industry experience)
  • Knowledge of EMA safety reporting regulations
  • Knowledge and training in ICH GCP, GMP, GDP and GLP
  • Experience with safety data collection, extraction, analysis
  • ICSR, CIOMS familiarity

Please contact Zoe Benningfield-Fox on ************* / ************* or email *************************** if you would like to know more about this opportunity. This will be 100% confidential.


This job was originally posted as www.jobsite.co.uk/job/959530096