Marketed Prod Safety Spec 2

4 days ago

Ahmedabad Gujarat, India IQVIA Full time

Job Overview
Develop and prepare pharmacovigilance agreements for assigned customers. 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 Req
- 3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience. 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.

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