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Senior Marketed Product Safety Specialist
IQVIA Holdings Inc.
Various Locations
RESPONSIBILITIES
- 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
- May assume the responsibilities of EU QPPV or deputy QPPV as outlined in Quintiles Work Instruction: CS_WI_LS0013 Lifecycle Safety-Qualified Persons for Pharmacovigilance (QPPV)
- Perform all other duties as assigned
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 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
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree or educational equivalent in health science or other directly related field and a minimum of 3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience or equivalent combination of education, training or experience.
PHYSICAL REQUIREMENTS
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Regular sitting for extended periods of time.
- May require occasional travel.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
Job posted: 2020-12-04