Essential Functions
- Maintain the local PV system compliant, according with local Legislation and GVPs.
- Work closely with project teams to determine appropriate terms and conditions of safety agreements.
- Act as primary point of contact or deputy 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 and PSSFs.
- Reviews PSMFs prepared by other specialists.
- Provide advice, support and guidance to other staff as needed.
- Perform all other duties as assigned
Qualifications
- Bachelor's Degree in health science.
- 2 years experience in a Contract Research Organization or Pharmaceutical company including at least 1 years of Lifecycle Safety experience (Local contact person for Pharmacovigilance, PSMF and PSSF management, PVA, Aggregate reporting, Risk Management, etc). 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.
- 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.