Senior Pharmacovigilance Associate

Position Summary / Objective

• 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.
  
• Relies upon medical knowledge to conduct comparisons of adverse event source documents against Safety Database screens for transcription and medical accuracy.
  
• Employs effective oral and written communication skills to ensure appropriate AE case processing and consistent documentation of medical judgment within the drug safety database.
  
• Maintains a customer service focus with internal and external GPV&E colleagues.
  
• 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.
  
• Takes personal initiative by proactively identifying innovative ways to accomplish tasks and driving toward process efficiencies.
  
• Utilizes effective organizational skills to prioritize deliverables in order to accomplish work in established timeframes.
  
• Demonstrates the ability to handle ambiguity of inquiries by identifying reporting regulations in order to provide solutions for resolution.
  
• 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.
  
• Collaborates with Medical Review Safety Physicians and Safety/ESR Scientists across therapeutic areas on case-related issues, while seeking guidance from AE Processing managers.
  

• Contributes to continuous quality improvement process through projects and other related departmental initiatives.
  
• Serves as a trainer, mentor, and guide for colleagues within GPV&E through providing perspective on the broad organizational impact on their daily work.
  
• 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.
  
• 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.
  
• Develop and execute training for alignment in processing.
  
• Collaborate with clinical trial teams and CROs to ensure SAE operational processes in outsourced clinical trials align with BMS processes.
  
• Ensure alignment and drive approval from all Stakeholders of study specific SAE Management Plans.
  
• Review and evaluate integrity of CRO SAE processes for inspection readiness.