Manager, Case Management, Individual Case Safety Reporting Processing

Job content

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.

This is a global role which supports the Worldwide Patient Safety vision through understanding the impact and implication of daily work deliverables, policies and procedures on all stakeholders of single case safety reporting. This commitment drives dedication to quality and adherence to global single case regulatory reporting requirements. This role provides oversight of the management and execution of Safety Data Processing from global sources through a Business Partner Model working with multiple global stakeholders across WWPS and external functions. The role requires oversight of productivity, quality and process optimization and ensures business continuity for compliance critical safety data processing to support regulatory obligations.

Position Responsibilities

• Performs ICSR Case processing activities within a matrix environment to achieve oversight and execution of global single case safety processing and reporting requirements in accordance with global regulations operating within a business partner optimisation model.
• Manage and execute day to day operational aspects of ICSR Case Processing in collaboration with Business Partners and stakeholder functions in order to ensure continuous compliance and high quality of ICSR process.
• Manage day to day oversight and executation of project related work as required supporting ICSR process optimization including implementation of regulatory requirements and standards.
• Contribute to the creation of a high performance culture through effective management and communication with internal and external stakeholders.
• Work in close collaboration with WWPS HQ functions including Case Processing Business Operations and local markets to ensure effective collection, collation, assessment and onward reporting of ICSRs to all applicable regulatory authorities, business partners and WWPS customers in accordance with applicable global regulatory requirements and WWPS principles.
• Contribute to development and maintenance of WWPS Case Processing conventions in collaboration with applicable stakeholders.
• Through development of technical subject matter expertise including mastery of ICSR case processing conventions and database functionality ensures oversight of defined end to end ICSR Case Processing activities and ensures the highest quality of ICSR case processing in accordance with established internal key performance indicators (KPIs) and regulatory expectations.
• Represent Case Management in PV audit and Regulatory inspections and contribute to subsequent CAPAs as needed.
• Work effectively with project teams, business partners, vendors and colleagues to ensure solutions are implemented in a timely manner.
• Drive innovation through identification of opportunities to leverage technology and process optimization in collaboration with applicable WWPS sub-functions not limited to BCI and Global Safety Systems in accordance with established QMS.
• Identify capabilities necessary to further enhance the case management organization in alignment with WWPS strategy
• Inspire and motivate peers to pursue excellence and identify methods for innovative process improvement and/or process efficiencies.
• Exhibits the BMS behaviors and values
  

Degree RequirementsBachelor’s degree (B.S./B.A.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy preferred.

Experience Requirements A minimum of 5 years experience (or equivalent) in processing adverse event reports, designing processes to ensure compliance with domestic and international safety reporting requirements and utilizing databases to support pharmacovigilance activities.

Key Competency Requirements

• Knowledge of international ICSR processing and reporting requirements, regulations, guidelines and procedures.
• Mastery of health / life sciences gained through either formal education or on job experiences.
• Demonstrated ability to analyze and interpret complex problems/data gathered from a variety of sources and, through effective decision-making and planning, delivers superior business solutions.
• Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to accomplish common goal.
• Experience of being able to successfully and productively supervise a team of individuals.
• First-hand experience of working directly with customers, technical experts and professional staff.
• Demonstrated ability to effectively communicate to a diverse audience, at multiple levels within the company, through various formats, i.e. presentations, written proposals/reports/correspondence, leading meetings, face to face dialogue.
• Knowledge of BMS development/planning processes and inherent limitations in order to know who and which resources to engage in making decisions and achieving business results.
• Understanding of organizational structure, operating culture, effective work styles, and achieving results in a change environment.
  

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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