Develop and prepare pharmacovigilance agreements for assigned customers. Preparation of pharmacovigilance system master files.
Act as EU QPPV for small clients.
Work closely with project teams to determine appropriate terms and conditions of safety agreements.
Act as primary point of contact on assigned projects and manage the pharmacovigilance agreement development process for large, complex projects and provide support as required.
Act as primary customer interface on large, complex projects, responsible for maintaining and developing customer relationships.
Customize project documents to accurately reflect services provided. Oversee finalization and distribution of documents.
Assist in the negotiation of safety agreement text using approved procedures and templates.
Create safety agreements as required, review complex agreements and provide guidance and advice to team.
Prepare and maintain PSMFs.
Reviews PSMFs prepared by other specialists.
Provide advice, support and guidance to other staff as needed.
Mentor and train team members.
Bachelor's Degree in health science or related area
5 years' clinical research experience in a Contract Research Organization or Pharmaceutical company including at least 3 years' of Lifecycle Safety experience (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc)
Excellent knowledge of Lifecycle Safety processes
Excellent attention to detail and accuracy and maintain consistently high quality standards.
Excellent written and verbal communication skills.
Effective mentoring 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 co-workers’, managers and clients.
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