Senior Pharmacovigilance Specialist
24 hours ago
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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