Safety Scientist Expedited Safety Reporting

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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.

Summary:

The function of the ESR Scientist group is to work in conjunction with the Vendor SUSAR Support Team and Medical Review Safety Physicians (MRSP) to identify and report ESRs within regulatory agency timelines worldwide.

• Prepares high-quality narrative summaries for expedited safety reports incl. responsibility to ensure all safety information is accurate, integrated and current, and is submitted within regulatory timelines.
• Participates in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports and scientific literature.
• Provides technical support to WWPS Medical Review Safety Physicians (MRSP) including review and interpretation of source documents.
• Identifies additional information required from investigators and collaborate with MRSP to prepare queries to obtain additional information.
• Utilizes BMS safety and clinical databases to prepare contextual summaries for expedited safety reports.
• Coordinates all activities around the preparation, evaluation, review and submission of expedited safety reports.
• Reviews and comments on documents and line listings from WWPS, other BMS departments, and other drug development/ marketing partners and contractors.
• Follows BMS WWPS and R&D SOPs, drug safety coding conventions, and work-aids.
• Performs analysis of Similar Events for SUSAR reports, potential DILI and events of special interest cases.
• Serves as a resource for WWPS to provide SUSAR-related information; helps develop and participate in and/or lead teams involved with developing or revising WWPS SOPs.
• Works with WWPS vendors & partners providing oversight/guidance for the ESR/SUSAR process.
  (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree/Experience Requirements

• Bachelor's degree and 4 years' experience in a clinical development setting or 1-3 years Safety experience within the pharmaceutical industry. BSN/RN, Master Degree (Life Sciences); B.S. Pharm./R.Ph./Pharm.D or equivalent is preferred but not required.

Key Competency Requirements

• Possess medical writing skills to produce accurate, concise, medically sound expedited reports.
• Experience using a drug safety database to capture adverse events.
• Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company and academic setting).
• Experience working in teams, including supporting other team members when necessary and the ability to lead a team.
• Strong prioritization skills to ensure that processes, procedures and best practices are consistent across WWPS; and that all applicable regulatory requirements are met in a timely manner with high quality.
• Ability to make constructive recommendations to improve processes.
• Demonstrates the ability to multi-task, and flexibility to meet changing business priorities.
• Ability to collaborate within multi-disciplinary team on drug safety-related issues including informing safety physicians and scientists within the therapeutic area on case-related issues.
• Ability to apply sound analytical thinking and database query skills to gather, review, summarize and evaluate critical information in a timely manner.
• Ability to apply medical, scientific and clinical knowledge in reviewing safety-related documents (e.g. protocols, investigator brochures, product labels, relevant source documents) and incorporating key concepts to clearly present the reported events, and in turn, maintain patient safety.
• Knowledge and understanding of Health Authority Regulations worldwide, how to access them and when to refer to them.
• Ability to support WWPS Vision and Mission through an understanding of the impact and implications of daily work on all customers of the Expedited Safety Reporting team.
• Project planning skills.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.