Senior Safety Associate

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Key Responsibilities and Major Duties:

Ensures the quality and accuracy of adverse event reports. Learns and navigates the intricacies of the BMS Drug Safety Databases (AWARE) to process adverse event reports. Relies upon medical knowledge to conduct comparisons of adverse event source documents against AWARE data 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 work to be accomplished and driving toward completion of that work. Utilizes effective organizational skills to prioritize deliverables in order to accomplish work in established timeframes. Demonstrates the ability to handle ambiguity of source material by identifying medical and regulatory reporting inconsistencies and offers possible solutions for resolution. Demonstrates strong teamwork skills to ensure that processes, procedures, and best practices are consistent across GPV&E and that quality 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 special projects and other related departmental initiatives.

Qualifications:

Minimum of 4 year life sciences or 4-year health related Pharm.D or BSN degree.

Three years of experience in pharmacovigilance or four years experience in clinical medicine/nursing/pharmacy or academic environment.

Experience working in a team environment and ability to function with a strong degree of confidence and make independent judgements. Broad knowledge of medical and scientific principles of human disease processes in conjunction with the intervention of pharmaceutical products

Computer literacy and demonstrated ability to learn new software applications.

Post-marketing and/or investigational drug safety reporting experience, including experience operating with an intricate drug safety database. Basic understanding of domestic and international drug safety regulations. Demonstrated research/writing/presentation/ training skills. Ability to consistently meet/exceed performance targets for quantitative productivity (and quality standards) during processing of individual adverse event reports. Ability to additionally contribute to strategic work initiatives and projects for continuous improvement of overall quality, efficiency and compliance for safety review processes.