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Company Name : IQVIA
Location : Thane, Maharashtra
Position : Marketed Prod Safety Spec 2
Job Description : Minumum 5+ yrs of experience in Pharmacovigilance with below skills is required.
RESPONSIBILITIES
Work closely with project teams to determine appropriate terms and conditions of safety agreements. A good understanding of GVP modules and global regulatory requirements with respect to PV timelines.Develop and prepare safety agreementsPrepare and maintain PSMFsReview PSMFs prepared by other specialistsPrimary customer interface on large, complex projects, responsible for developing and maintaining customerrelationshipsProvide input to project plans to accurately reflect services provided. Oversee finalization and distribution of safety agreementsAssist in the negotiation of safety agreement text using approved processes and templates.Represent safety agreements team at customer meetings as requiredProvide input into project budgets involving safety agreements.Provide advice, support and guidance to other staff involved in preparing safety agreements.Mentor and train team membersMay 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
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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