Senior Pharmacovigilance Scientist

Recruiter
CK Group
Location
Cambridge
Salary
Up to £549 per day LTD
Posted
07 May 2021
Closes
14 May 2021
Ref
50568
Contact
Dennis Beltman
Contract Type
Contract
Hours
Full Time
CK Group are recruiting for a Senior Pharmacovigilance Scientist to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 6 or 12 months.

Company:

Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

Location:
This Senior Pharmacovigilance Scientist role will be fully remote based.

Salary:
Up to £549 per day LTD.

Senior Pharmacovigilance Scientist Role:
  • Lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
  • Lead the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects.
  • Present complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
  • Lead and author the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed.
  • Author/provide strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
  • Author/provide strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.

Your Background:
  • A Life Sciences/Pharmacy/Nursing degree, and demonstrated Patient Safety and/or Clinical/Drug Development experience.
  • Experience in risk management activities and authoring/updating Risk Management Plans (RMP).
  • Advanced knowledge of PV regulations.
  • Intermediate understanding of epidemiology, preferred.
  • Experience in signal detection, management and evaluation.

Apply:
For more information or to apply for this Senior Pharmacovigilance Scientist position, please contact CK Grouo, quoting job ref 50568.

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

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