Achieva Group Ltd

Drug Safety Specialist

Location
Hertfordshire
Salary
£35 - £45 per hour
Posted
19 Feb 2021
Closes
21 Mar 2021
Ref
BH-25475
Contact
Sophie Fosh
Discipline
Clinical Research
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Our global pharmaceutical client has a vacancy for a Drug Safety Specialist, ICSR Professional.
 
Our client is looking for candidates based in the UK.
 
This is a 6-month full time contract.
 
The aim is to find a candidate with pharmacovigilance expertise, particularly individual case safety report (ICSR) knowledge, to ensure safety data is processed and reported in a high quality, compliant manner, so it can be used to understand and communicate the product benefit risk to protect patients’ safety.
Main responsibilities:
  • Profound knowledge of assigned topics and regulations within ICSR case processing, & strong broad knowledge across the end to end ICSR process in line with the expectations of the key stakeholders.
  • Accountable leader, who role models proactive, self-motivated process development and issue management
  • Critical thinker who can see the bigger picture in order to connect processes, data, ideas and people.
Self-motivated to learn about new data sources, new regulations, and seek to co-create new solutions when required.




Qualifications and experience:

  • Evidence of advanced learning e.g an undergraduate degree, however on-the-job pharmacovigilance experience would be equally considered.
  • Ideally the candidate would have demonstrated experience in a breadth of areas pertaining to pharmacovigilance, and pharmacovigilance legislation; good knowledge of international regulations (ICH, EU GVP Modules, FDA) and an understanding of the pharmaceutical industry (product development and the commercial environment) and of rapidly-evolving personalised health care environment and ecosystem.

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