05 Oct
|
Iqvia
|
Hyderabad
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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We
📌 Marketed Prod Safety Spec 2 (Hyderabad)
🏢 Iqvia
📍 Hyderabad