Pharmacovigilance (PV Agreements) Senior Specialist
IQVIA
Bucharest, Ilfov, Romania
3 zile în urmă

Job Overview

IQVIA is seeking a Safety Data Specialist for Pharmacovigilance (QPPV) to develop and prepare pharmacovigilance agreements for an assigned customer.

Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV.

Essential Functions

  • Work closely with project teams to determine appropriate terms and conditions of safety agreements.
  • Develop and prepare safety agreements.
  • Prepare and maintain PSMFs.
  • Review PSMFs prepared by other specialists. Primary customer interface on large, complex projects, responsible for developing and maintaining customer. relationships.
  • Provide input to project plans to accurately reflect services provided.
  • Oversee finalization and distribution of safety agreements.
  • Assist in the negotiation of safety agreement text using approved processes and templates.
  • Represent safety agreements team at customer meetings as required.
  • Provide input into project budgets involving safety agreements.
  • Provide advice, support and guidance to other staff involved in preparing safety agreements.
  • Mentor and train team members.
  • Perform all other duties as assigned
  • Qualifications

  • Bachelor's Degree Preferably in health science or related area
  • Experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) ideally with project management experience.
  • or Equivalent combination of education, training or experience.

  • Excellent knowledge of Lifecycle Safety processes.
  • Excellent attention to detail and accuracy and maintain consistently high quality standards.
  • Excellent written and verbal communication skills.
  • Ability to work effectively on multiple projects simultaneously.
  • Organize own workload and effectively time manage competing priorities.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

    We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at

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