Global Regulatory Sciences and Pharmacovigilance
In Global Regulatory Sciences and Pharmacovigilance, our overall goal is to get safe and effective medicines to patients faster. We live and breathe patient safety. We also focus on leading the innovative dialogue between the company and our scientists to make new development methods (biomarkers, modeling and simulation, seamless clinical trial designs, etc.) eligible for regulatory decision-making.
Regulatory Sciences
We are the primary communication link between Bristol-Myers Squibb and worldwide regulatory agencies, such as the U.S. Food and Drug Administration. In addition, we serve as the primary communicator of the laws, regulations, guidelines and guidances from these regulatory agencies to the other members of the company’s research, development, manufacturing and commercial staff. As such, we interact with the vast majority of the other departments within the company.
Historically, we’ve supported the development and registration of medicines, and ensured that product information for regulatory agencies accurately reflects the benefits and the risks of our medicines, as well as how to use them appropriately.
We also play a role in helping our development teams generate the critical data to support our registration claims, and satisfy formulary requirements. Today we need to think about payers and insurance companies to give them the information they need to understand the benefit of our medicines for patients.
We have adopted the innovative approach of fostering face-to-face interaction between our development scientists and the critical regulatory scientists. Having this scientist-to-scientist interaction with the health authority early in a drug’s development has the potential to streamline the development process. When we are talking about patients with serious diseases and significant unmet medical need, scientists understand the sense of urgency and will reach a consensus in a much more collaborative way.
People come to work here because they’re listened to and they see an opportunity to influence the development process and bring new medicines to patients. At Bristol-Myers Squibb, we treat each other with courtesy and respect, and we’re accountable for each other’s success.
We seek to fill critical positions for physicians, biologists, chemists, Ph.D.s, and Pharm.D.s who display excellent scientific, clinical or pharmaceutical development knowledge. Credentials are expected, but so is personal integrity and passion.
Pharmacovigilance
Our goal is to minimize adverse events, and when they occur, to analyze them quickly, communicate them appropriately and introduce measures to minimize the risk to our patients.
As long as the company studies or markets a drug, anywhere in the world, we monitor it. Our focus on continuous improvement includes a recently completed comprehensive transformation of our pharmacovigilance organization, including the structure, processes and operating model. We are now considered the company that sets the industry standards in this area.
More than 70,000 adverse event cases that come into the company each year are reviewed by, and receive a medical recommendation from, a physician. And all this is accomplished within industry-leading cycle times.
The Pharmacovigilance group works across the entire portfolio of Bristol-Myers Squibb products. Our engagement spans the full life-cycle of a product, from the planning of the first-in-human investigational trials through the duration of its global marketing.
Operationally and through the medical governance, we are embedded in both early and full development teams, as well as life-cycle and mature product teams. These responsibilities span compliance activities, medical safety strategies and risk benefit issues.
We look for a variety of technical skills and educational backgrounds, from associate degrees to Ph.D.s and M.D.s. We require nurses and pharmacists to perform first-line safety reviews, physicians to assess product safety, scientists to analyze the data software specialists to automate the data, and epidemiologists to conduct population studies and assess the risk to specific populations. All are equally essential to our company’s success.
We look for leaders who can manage people and projects, who are both science and business minded. We encourage talented and motivated achievers, who can think creatively and have a desire to develop groundbreaking practices, to join us on our journey to enhance and extend human life.