Bristol Myers Squibb Company

Manager, Safety Surveillance & Aggregate Reporting

Location
Celgene, NJ, United States
Posted
Sep 11, 2020
Ref
R1527039
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary:

Reporting to the Associate Director, Worldwide Patient Safety (WWPS), Aggregate Safety Reporting (ASR), the primary role of the Manager is to support Aggregate reports, ad-hoc responses, medical surveillance to support early life cycle management, safety data summaries, and gap-analyses in publishing-ready format.

Responsibilities include, but are not limited to, the following:
  • Author and/or support safety documents such as medical surveillance strategy to support early life cycle management, safety data summaries, and gap-analyses as needed using the appropriate template
  • Author and/or support aggregate reports (PSURs, DSURs, Addendum reports, and US PSRs) and other ad-hoc safety reports & responses using the appropriate template
  • Liaise with Medical Writing team members, other members of WWPS, and other departments such a Medical Affairs as needed
  • Adhere to the project schedule for each report
  • Update and edit aggregate reports, ad-hoc reports and other safety documents during review cycles
  • Ensure thorough review of documents (both self-review and peer review) for data accuracy, consistency, correct use of grammar and consistency with the Style Guide prior to sharing with others for review
  • Attend report Kick off, Strategy and Comment Resolution meetings, and other meetings that are scheduled in the course of daily activities
  • Provide reports and responses in publishing-ready format.
  • Attend training as appropriate/assigned
  • Raise any concerns regarding content or process to the Associate Director in a timely manner


Qualification/Experience Required:
  • Minimum of BA/BS in life science or clinical science. Advanced degrees are preferred but not required (BSN, RN, PhD, Masters, PharmD)
  • Minimum of three years relevant experience in pharma/biotech, preferably with experience in patient safety and writing
  • Experience with safety databases (Argus, ARISg, other similar databases) and their output
  • Expertise in Medical and/or Scientific Writing


Knowledge/Skills/Competencies Required:
  • English language expert; strong writing, editing and proofreading skills and interpersonal skills to ensure a team-oriented approach
  • Excellent communication skills (written & oral) with understanding of medical terminology
  • Ability to integrate, analyze, interpret and summarize data from a variety of sources in a clear and concise manner.
  • Ability to demonstrate a familiarity with principles of PV and to interpret and present clinical and post marketing data with strong knowledge of clinical trials & drug development
  • Strong knowledge of FDA and EMA regulations and guidelines, as well as ICH guidelines
  • Appreciation of the global safety environment, international regulations & guidance documents
  • Knowledge of drug development process
  • Clinical knowledge of therapeutic areas, patient populations & drug classes
  • Knowledge of interpretation & presentation of aggregate safety data
  • Ability to work as part of a team with minimal supervision, multi-task, and meet internal and regulatory deadlines
  • Sense of urgency, confidence in making decisions, organization and planning skills, meticulous, critical thinker, keen attention to detail
  • Ability to work on a global multifunctional team
  • Ability to thrive in a global matrix environment
  • Familiarity with AMA style guide
  • Strong proficiency in MS Word, Excel, Outlook, PowerPoint
  • Experience with the use of SharePoint
  • Experience with the use of document management systems
  • Familiarity with safety database output (Argus, ARISg, other) and Business Objects


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.