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Manager Pharmacovigilance & Epidemiology

Collabera Europe ltd
Job LocationCambridge
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Reports to: Senior Director, Pharmacovigilance & EpidemiologyPVE is organized within four discreet areas plus the EU QPPV. The areas include: PVE Operations - This group is responsible for case processing from receipt through to submission to external parties and is also responsible for the operational support of clinical studies. Medical Safety Science - This group covers the medical input and scientific evaluation of safety data including ICSRs, aggregate data, risk management plans, aggregate reports and signal detection.Epidemiology - This group provides epidemiological support throughout all stages of a product lifecycle.Standards and Collaborations (S&C) is the group where the vacancy exists, and the role is based in Cambridge UK. This group is responsible for safety language in contracts, vendor oversight of safety information reporting for global Patient Assistance and Support Programs, market research and social listening projects, authoring Pharmacovigilance agreements (PVA) with license partners and CROs, audit and inspection readiness/support, pharmacovigilance training, Management of the Pharmacovigilance System Master File, PV compliance and quality measures and managing the Pharmacovigilance Responsible Persons in Clients global affiliates and supporting PV in Distributor countries across the world.At a minimum, the ideal candidate will possess:

  • Scientific background with a medico-scientific university degree
  • Previous experience in multiple aspects of pharmacovigilance activities
  • Project management experience preferred or experience in managing complex projects
  • Working knowledge of global safety regulatory requirements
  • Proven good communication skills and evidence of ability to work in cross functional teams
    • Essential Duties and Job Functions:
  • Establishes work priorities with minimal direction from manager. Work is performed without appreciable supervisory direction
  • Provides regular updates to manager, including challenges and suggested actions that could be taken
  • Able to maintain confidentiality (especially on patient records), with good attention to detail and a high level of concern for accuracy and quality
  • Actively participates in S&C meetings and shares information on projects and challenges openly
  • Recognizes potential or impending problems, implements and delivers solutions
  • Maintains compliance with PVE and applicable SOPs and work instructions
  • Maintains knowledge of company disease and therapeutic areas
  • Has a good knowledge and understanding of applicable regulatory requirements.
  • Exercises some latitude in determining objectives and approaches to assignment
  • Develops solutions to complex problems which require the regular use of ingenuity and innovation, ensuring solutions are consistent with organization objectives; contributes to the development of new concepts, techniques, and standards
  • Serves as consultant to PVE management in area of expertise and acts as a spokesperson for the PVE organization in matters pertaining to its policies, plans, and objectives in their area of expertise
  • Makes and effects decisions that are long-lasting and influence the future course of the PVE organization

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