Senior Marketed Product Safety Specialist

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.