Director Expedited Safety Reporting

Profile

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.

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Position: Director, Expedited Safety Reporting (Ref: 1611)

Location: 3551 Lawrenceville Road, Princeton, NJ 08540

Duties: Utilize knowledge of expedited safety reporting process, SOPs, conventions and health authority regulations worldwide to lead a team to ensure that processes, procedures and best practices are consistent across Worldwide Patient Safety and that regulatory requirements are met in a timely manner. Accountable for ensuring safety information is submitted within regulatory timelines. Utilize medical writing skills to ensure production of accurate, concise, medically sound expedited reports by Expedited Safety Reporting (ESR) scientists suitable for submission to regulatory health authorities, IRBs (Institutional Review Boards) and investigators. Utilize medical, scientific and clinical knowledge in reviewing safety-related documents (e.g. protocols, investigator brochures, product labels, relevant source documents) and incorporate key concepts to clearly present and assess the reported events, and in turn, maintain patient safety. Collaborate and manage within a multi-disciplinary team regarding drug safety-related issues. Manage and develop ESR Safety Scientists. Serve as the Subject Matter Expert on cross-functional teams; is empowered to make decisions within area of expertise and responsibilities. Make constructive recommendations to improve processes and lead process changes. Review and evaluate critical information in a timely manner. Responsible for Pharmacovigilance Agreement content related to expedited safety reporting. Oversees SUSAR ( Suspected Unexpected Serious Adverse Reaction ) Support Team at off-shore vendor where the off-shore team is responsible for data entry and assessment of information into the Corporate Safety Database as well as scientific writing related to expedited safety reports.

Requirements: Bachelor's degree in Health Sciences, Medical or a related field plus 5 years of experience in pharmaceutical product safety reporting and management showing demonstrable ability in the skills set described above.

** This position is eligible for our employee referral program

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.

Company: Bristol-Myers Squibb

Req Number: R1526925_EN

Updated: 2020-06-19 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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