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Senior Global Safety Associate

ARM LifeSciences
Job LocationCambridge
EducationNot Mentioned
Salary£25.00 - £28.89 per hour
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Senior Global Safety Associate - 12 month contract - WFH (Cambridge)My client who are a global Biopharmaceutical business based in Cambridge are looking for a Senior Global Safety associate to join their business on a 12 month project. The role has come available due to operational workload being increased due to Covid as the medical and commercial team are setting up new patient programmes to help patients get the right medicine to be released from hospital. Patient numbers being increased and Brexit activities are other reasons for the role being created.Key must haves:

  • 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.
  • CRO background or homecare provider would be suited
    • You will be working in the UK and Ireland Affiliate Safety Department, and reporting to the Global Safety Senior Manager, this role will be responsible for ensuring adherence to regulatory commitment for pharmacovigilance.You will be will performing a wide variety of safety activities within the local affiliate, based on sound knowledge of local legislative requirements and company procedures. The role involves collaboration with other affiliate functions and also with Global Safety colleagues to meet business needs.Key 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 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.• Key contact: Serves as key contact for defined safety activities within the affiliate.• 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.Person:You must be a natural team player with the personal qualities to relate well to people at all levels. With a customer oriented approach and confident communication skills, you will work well within a cross functioning team. You will have the ability to organise and maintain accurate records with unquestionable attention to detail. In addition, you will be highly motivated, quick to learn, flexible and analytical.Candidate will WFH for the interim but when staff are permitted to return to work they will be based from Cambridge. Required skills
  • Case Management
  • Drug Safety
  • Patient Safety
  • Pharmacovigilance
  • Pharmaceutical Industry

    • Keyskills :
    Case Management Drug Safety Patient Safety Pharmacovigilance Pharmaceutical Industry

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