Senior Triage 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.
- Participate in clinical research by assessing incoming reports and evaluate the information contained therein to determine the seriousness of the report and determine contractual responsibilities in order to assign a regulatory due date, by drawing on experience with adverse events; drug safety reporting requirements, guidelines and processes; sections of US and foreign product labels; SUSAR (Suspected Unexpected Serious Adverse Reaction) identification; proper and legal product dosage and indications; drug safety processes and workflow; FDA and ICH guidelines for drug and device reporting; and clinical trials structure and reporting requirements.
- Identify all related clinical study cases for Semi-annual report of Suspected Unexpected Serious Adverse Reaction (SUSAR). Identify potential signal detection cases and communicate this to the Medical Review Safety Physician (MRSP).
- Organize work load in order to prioritize the most urgent deliverables (i.e. reports) ultimately to execute accurate reportable timelines. Seek to understand and adhere to Safety Data Exchange Agreement (SDEA) in processing cases involving products under co-marketing arrangements in order to handle all cases in a timely manner.
- Serve as a resource to identify company products and designated co-marketers. Oversee that all follow up cases go into the appropriate case based on Individual Case Safety Reports (ICSR) and also liaises with MRSP if needed. Develop and execute training for alignment in processing.
- Be accountable for multiple tasks and task prioritization according to designated criteria and remains flexible as processes and priorities change. Exercise a high degree of adaptability in dealing with an ambiguous and complex work environment, which includes demands not only from respective teams, but also from regulatory agencies, co-marketing partners and the Global Pharmacovigilance and Epidemiology (GPV&E) Medical staff.
- Serve as a trainer, mentor, and guide for colleagues within GPV&E through providing perspective on the broad organizational impact on their daily work. Coordinate the daily responsibilities and workload of the team by deploying resources and delegating appropriately and equitably in order to meet short term and long term goals defined for adverse event processing.
Requirements: Master's degree in Pharmacy, Pharmaceutical Management, Health or Life Sciences with 2 years of experience or a Bachelor's degree with 5 years of experience with adverse events; drug safety reporting requirements, guidelines and processes; sections of US and foreign product labels; SUSAR (Suspected Unexpected Serious Adverse Reaction) identification; proper and legal product dosage and indications; drug safety processes and workflow; FDA and ICH guidelines for drug and device reporting; and clinical trials structure and reporting requirements reflecting demonstrable ability in the skill set described above.