Job Description

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.

The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

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 office based role, with focus area of Coding Data Sheets, Auto Labeling, RSI, supports 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.

Position responsibilities include but are not limited to:

• Delivering accurate and consistent medical coding within established timelines and in compliance with all processes, guidelines and conventions.
• Interfaces with colleagues from external teams on coding related matters and serves as the medical coding subject matter expert within WWPS.
• Ensuring coding with MedDRA, UMC WHODrug, or company specific dictionary is clear, appropriate and complete based upon the investigator’s entry on the CRF and coded in compliance with all processes, guidelines and conventions.
• Knowledge of general clinical research and of the pharmaceutical industry. Thorough understanding of Regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.
• When required, 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 execution 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 organisation 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 behaviours and values

Degree Requirements

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

Experience Requirements

A minimum of 3-5 years of experience with RSI and coding of adverse event in safety or clinical setting, demonstrated knowledge of hierarchical dictionary reporting dictionaries; MedDRA and UMC WHODrug, understanding of the versioning and maintenance of MedDRA, understanding of medical concepts, biology and chemistry in support of medical coding. Thorough understanding of regulations, GCP, ICH Guidelines as they apply to coding of medical terminology. 

Other 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 analyse 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.
• 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 recognises 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. 
 
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. If you require reasonable adjustments in completing this application, or any part of the recruitment process direct your enquiries to adastaffingsupport@bms.com. Applicants can request an approval of an adjustment prior to accepting a job offer.