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Senior Pharmacovigilance Manager

  1. Remote
Remote work
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
33793
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Senior Pharmacovigilance Manager - Remote/UK - 12-Month Contract

We have an exciting opportunity for a Senior Pharmacovigilance Manager to work for a fast-growing global pharmaceutical company with a leading portfolio of innovative treatments. They are focused on critical care and rare diseases and are looking for a Senior Pharmacovigilance Manager for their UK and remote based location.


Responsibilities:
  •  Day to day management of the PV Team.
  • Ongoing monitoring of the safety profile of our clients medicinal products and continuous overall safety evaluation during the post-authorisation period.
  • Oversight of Individual Case Safety Reports (ICSRs), Standards Operating Procedures (SOPs), authoring aggregate reports (PSURs and PADERs) and Safety Data Exchange Agreements (SDEAs).
  • PV SME for Risk Management Plans (RMP), Post Authorization Safety Study (PASS) protocols, Risk Minimisation Strategies, effectiveness of follow-up measures, post-marketing commitment and e-transmissions to competent authorities.
  • Audit/inspection readiness for the PV audits, ensuring successful audit/inspection outcomes and ensuring findings are appropriately addressed and closed timely.
  • Ensuring the 5-year audit plan for pharmacovigilance is executed as planned, maintained on an ongoing basis and ensuring the pharmacovigilance system is fully audited on a rolling 5-year basis.
  • Author or review and sign off aggregate reports (PADERs and PSURs), Risk Management Plans particularly if they relate to drug safety, to assure that quality is maintained and that benefit/risk information is accurate and not misleading.
  • Ensure departmental compliance with EU, US, Canadian and other relevant global pharmacovigilance regulations

Requirements:
  • A medical or Life Science Degree
  • Minimum 5 years experience in the pharmaceutical industry, with solid experience in pharmacovigilance
  • A good understanding of normal and pathological physiological function
  • Experience with product-oriented contact with doctors and patients
  • Experience of managing outsourced activities
  • Proficient in developing and implementing programs and policies
  • Strong exposures of authoring and review and sign off aggregate reports (PADERs and PSURs), Risk Management Plans particularly if they relate to drug safety, to assure that quality is maintained and that benefit/risk information is accurate and not misleading.

 If this role is of interest to you, please apply now! 

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