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Drug Safety Associate Argus

PE Global
Job LocationCambridge
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

PE Global is currently recruiting for a Drug Safety Associate (Argus) for a leading multi-national Biotech client in Cambridge.Responsibilities:

  • Legislation: Maintains own current knowledge of and compliance with local safety regulations.
  • Product knowledge: Maintains awareness of current prescribing information (e.g.SmPC), safety profiles and new risk information for designated client products, to support product safety activities.
  • Case management: Manage business critical “core” safety activities per legal deadlines including intake of AE reports, follow up with HCPs for complete data, ICSR & aggregate safety report submission to regulators. Review metrics to monitor MHRA & HPRA submission compliance.
  • Cross-functional work: Collaborate with other affiliate departments including medical and commercial, to provide safety input into cross-functional initiatives (e.g. Patient Support Programs). Ensure PV compliance in these initiatives while understanding local business needs.
  • PV Review: May assist with safety review of local study protocols, market research programs and social media projects.
  • Audit: Assists safety team during audits and inspections of PV operations
    • Requirements:
  • Drug safety experience, pharmacovigilance experience (2-3 years)
  • The team covers, clinical trials and post market safety - more focus on post market experience (only clinical trials experience wont be suitable)
  • The safety database used Argus - bonus if they have this but not a prerequisite.
    • Interested candidates should submit an updated CV.Please click the link below to apply, call Amparo on + or alternatively send an up to date CVAlthough it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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