Drug Safety Specialist
- Company
- Achieva Group Ltd
- 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:
Qualifications and experience:
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.
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.