Senior Pharmacovigilance Specialist

24 hours ago


La Jolla, California, United States Allen Spolden Full time
Job Title: Senior Pharmacovigilance Associate

Job Summary:

We are seeking a highly skilled Senior Pharmacovigilance Associate to join our team at Allen Spolden. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the quality and accuracy of adverse event reports.

Key Responsibilities:

  • Ensure 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

Benefits:

Medical & Dental, 401K and PTO



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