Manager, Case Management, Individual Case Safety Report Processing, Safety Gateway

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Division

Research and Development / Global Regulatory & Safety Sciences /   

Worldwide Patient Safety / Global Operations / Case Management/ Individual Case Safety Report Processing  

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of BMS medicines: 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. 

Position Summary

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 Procesing 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

• Oversight of Safety Gateway activity to ensure the data entered in Clinical Data Management System required for safety case processing is successfully and correctly transmitted to the Corporate Safety Database 
• Safety Gateway mapping: collaboration with Rave Database Developers to review of mapping of studies for transmission to Rave to the Safety database
• Sagety Gateway UAT
• Review of the Safety Gatway file with NO SAE (check of missing 1 of 4 elements)
• Check of E2B failure import
• Review and reconcile cases in data listing for BMS EDC active studies not transmitted via Safety Gateway
• Oversight of Safety queries in Rave
• Request access to Rave for the case processing team
• Training the Case Processing tram on Safety Gateway studies specificities
• Writing Safety Gateway procedures
• Supporting transition from transition of studies among clinical platforms and transmission to the Safety Database (i.e from Oracle Clinical to Rave)
• Review and promptly address submission related correspondence in the AEP mailbox
• 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 
• Represent Case Management in PV audit and Regulatory inspections and contribute to subsequent CAPAs as needed. 
• 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 Requirements

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

Experience Requirements
 

A minimum of 5years 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. 
• Technical Proficiency: Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows.
• Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods.
• Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams
• Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data.
• Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments.
• Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality.
• Strategic Thinking: Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies
• Decision-Making:  Uses data summaries to support decisions based on clearly defined options and guidelines
• Change Management: Supports digital change initiatives and communicates their immediate benefits

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.