- Expiry Date: 11 February 2022
Functional Area Description: The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
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
Ensures the quality and accuracy of adverse event reports. Learns and navigates the intricacies of the 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 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.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Degree Requirements Bachelor’s degree, Scientific/medical background (B.S./B.A) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy preferred
Experience Requirements Minimum of 3-5 years pharmaceutical experience preferred.
Key Competency Requirements
Mastery of health / life sciences gained through either formal education or on job experiences.
Mastery of AE processing both internally and externally, as well as the ability to understand the future impact.
Mastery of the intricacies of the drug safety database.
Knowledge of drug development and commercialization process and the impact of AE Processing on that process.
Knowledge of general safety reporting requirements, regulations, guidelines and procedures.
Experience working with a wide range of technically and culturally diverse people and influencing them to accomplish a common goal.
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