Senior Pharmacovigilance Associate

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• Ensures the quality and accuracy of adverse event reports. Learns and navigates the intricacies of the BMS Drug Safety Databases to process adverse event reports.
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• Relies upon medical knowledge to conduct comparisons of adverse event source documents against Safety Database screens for transcription and medical accuracy.
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• Employs effective oral and written communication skills to ensure appropriate AE case processing and consistent documentation of medical judgment within the drug safety database.
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• Maintains a customer service focus with internal and external GPV&E colleagues.
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• Utilizes cultural awareness to incorporate the varying medical philosophies of regulatory bodies worldwide and the idiosyncrasies of health care delivery for effective global AE reporting.
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• Takes personal initiative by proactively identifying innovative ways to accomplish tasks and driving toward process efficiencies.
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• Utilizes effective organizational skills to prioritize deliverables in order to accomplish work in established timeframes.
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• Demonstrates the ability to handle ambiguity of inquiries by identifying reporting regulations in order to provide solutions for resolution.
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• Demonstrates strong teamwork skills to ensure that processes, procedures, and best practices are consistent across GPV&E and that regulatory requirements are met in a timely manner and with high quality.
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• Collaborates with Medical Review Safety Physicians and Safety/ESR Scientists across therapeutic areas on case -related issues, while seeking guidance from AE Processing managers.
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  • Contributes to continuous quality improvement process through projects and other related departmental initiatives.
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  • Serves as a trainer, mentor, and guide for colleagues within GPV&E through providing perspective on the broad organizational impact on their daily work.
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  • Accountable for multiple tasks including CAPA, ICSR reconciliation, database interfaces, single case compliance, external and internal stakeholder correspondence, and prioritizes tasks according to designated criteria.
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  • Utilizes knowledge of specific work practices, Standard Operating Procedures (SOP), and regulations in order to maintain oversight of vendor activities to ensure successful execution of tasks.
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  • Develop and execute training for alignment in processing.
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  • Collaborate with clinical trial teams and CROs to ensure SAE operational processes in outsourced clinical trials align with BMS processes.
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  • Ensure alignment and drive approval from all Stakeholders of study specific SAE Management Plans.
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  • Review and evaluate integrity of CRO SAE processes for inspection readiness.
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    Benefits<\/h3>

    Medical & Dental, 401K and PTO. <\/div><\/span>