Senior PV Scientist

7 days left

Up to £65 phr
03 Feb 2021
05 Mar 2021
Hendre Moolman
Full Time
Contract Type
Experience Level
Senior Management
CK Group are recruiting for a Senior Safety Scientists to join a pharmaceutical company based in Welwyn on an initial 12-month contract basis - Outside of IR35

This company is one of the world's largest biotech companies and is a leading provider of cancer treatments and in vitro diagnostics.

The Senior Safety Scientists in Pharmacovigilance position will be remote based. The offices are easily reachable by road (A1M) and also by rail (25 mins from Kings Cross), if you were required to visit the office for a meeting.

The Role:
The main purpose of the role will be to:
  • Support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management
  • Perform signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management
  • Take responsibility for individual and aggregate case reporting activities including ICSR case management and aggregate reporting
Further responsibilities will include:
  • Contributing to risk management activities including preparation and maintenance of CCDS, labelling document maintenance, and risk communications
  • Contributing to study management from a safety perspective and document review and maintenance across the development continuum
  • Contribute to regulatory authority by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL and PCS Team Lead
Your Background:
To succeed in this role, you will come from a Life Science background and previous industry experience in Pharmacovigilance
  • Understanding of GxP and regulated processes and end to end clinical trial lifecycle
  • Understanding of project management methodology
Quote job ref 49738.

It is essential that applicants hold entitlement to work in the UK

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