What are the responsibilities and job description for the Pharmacovigilance Associate position at Allen Spolden?
Position Summary / Objective
Supports the Worldwide Patient Safety Vision through understanding the impact and implication of daily work on all customers of AE Processing. This commitment drives dedication to quality and accurate case handling, for overall contribution to a high performance team.
Position Responsibilities
- 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.
