Position Summary This is a global role which supports the Worldwide Patient Safety Vision through understanding the impact of daily work on all stakeholders of Safety Data Processing.
This role provides oversight of quality and process optimization through a Business Partner Model working with multiple global stakeholders across WWPS and external functions to ensure business critical safety data processing to support regulatory obligations.
Primary focus will encompass review and reconciliation of adverse event data for safety reporting to Worldwide Patient Safety and from clinical trials in the clinical database.
This role includes oversight of SAE reconciliation activities to ensure all reportable events deemed appropriate for submission to regulatory agencies, per global regulations, are collected in both the clinical and safety database.
Position Responsibilities Ensure the quality and accuracy of adverse event reports. Learn and navigate the intricacies of the BMS Drug Safety Database to process adverse event reports.
Employ effective oral and written communication skills with multiple global stakeholders across WWPS and external stakeholders.
Maintain a customer service focus with internal and external WWPS colleagues. Take personal initiative by proactively identifying innovative ways to accomplish tasks and drive toward process efficiencies.
Utilize effective organizational skills to prioritize deliverables to accomplish work in established timeframes. Demonstrate strong teamwork skills to ensure that processes, procedures, and best practices are consistent across WWPS and that regulatory requirements are met in a timely manner and with high quality.
Collaborate with Medical Review Safety Physicians and Safety / ESR Scientists across therapeutic areas on case-related issues, while seeking guidance from ICSR End to End managers.
Contribute to continuous quality improvement process through projects and other related departmental initiatives. Utilize knowledge of specific work practices, Standard Operating Procedures (SOP), and regulations to maintain oversight of vendor activities to ensure successful execution of tasks.
Position Requirements Bachelor’s degree, Scientific / medical background (B.S / B. A) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy preferred.
A minimum of 3 to 5 years’ experience in processing serious adverse events from clinical studies and from post-marketing reports.
Knowledge of general, including international, ICSR processing and reporting requirements, regulations, guidelines and procedures.
Mastery of health / life sciences gained through either formal education or on job experiences. Mastery of safety data processing, as well as the ability to understand the future impact.
Mastery of the intricacies of the BMS drug safety database. Experience working with a wide range of technically and culturally diverse people and influencing them to accomplish a common goal.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.
S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.
Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.
This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana.
This requirement is also subject to discussions with collective bargaining representatives in the U.S.