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Manager, Case Management Safety Reconciliations

Bristol Myers Squibb


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3-5 Years
25 days ago
36 Viewed
1 Applied

Job Description

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 .

Functional Area Description

  • The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines; 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 of daily Safety Data Processing work on all stakeholders. 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 in the Worldwide Patient Safety database and data in the clinical trial database. This role includes oversight of SAE reconciliation activities between the clinical and safety databases. Includes active performance of SAE reconciliation, medical coding review and data listing review, as well as management of tracking tools to support Clinical Trial reconciliation. Scope includes additional forms of safety reconciliation internal and external to BMS such as Medical Information, Business Partner, Customer Service Agreements, Patient Support Program, Investigator Sponsored Studies, Specialty Pharmacy, Social Media, Customer Care REMS,SUSAR Reconciliation, and others as identified to ensure data integrity and quality of AE information held within the Corporate Safety Database to facilitate benefit, risk evaluation and additional pharmacovigilance activities conducted by Worldwide Patient Safety.

Position Responsibilities

  • Ensure the quality and accuracy of adverse event reports. Learn and navigate the intricacies of the BMS Drug Safety Databases to process adverse event reports.
  • Rely upon medical knowledge to conduct comparisons of adverse event source documents against Safety Database screens for transcription and medical accuracy.
  • Rely upon medical knowledge to conduct comparisons of adverse event source documents against Safety Database screens for transcription and medical accuracy
  • Demonstrate the ability to handle ambiguity of inquiries by identifying reporting regulations to provide solutions for resolution and escalate issues in contract agreements to senior management as appropriate
  • Participate in review, update and execution of study/vendor specific related documents including but not limited to safety management plan (SMP), Pharmacovigilance Agreement (PVA) and Safety Data Exchange Agreements (SDEA)
  • Act as SME in Safety database configurational matters
  • Assist with CRO, vendor oversight activities
  • Assist with inspection readiness activities related to areas of focus
  • 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.
  • Utilize cultural awareness to incorporate the varying medical philosophies of regulatory bodies worldwide and the idiosyncrasies of health care delivery.
  • Take personal initiative by proactively identifying innovative ways to accomplish tasks and drive toward process efficiencies.
  • Utilize effective organizational skills to prioritize deliverables in order to accomplish work in established timeframes.
  • Demonstrate the ability to handle ambiguity of inquiries by identifying reporting regulations in order to provide solutions for resolution.
  • 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.
  • Serve as a trainer, mentor, and guide for colleagues within WWPS by providing perspective on the broad organizational impact on their daily work.
  • Utilize knowledge of specific work practices, Standard Operating Procedures (SOP), and regulations in order to maintain oversight of vendor activities to ensure successful execution of tasks.
  • (Disclaimer The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree Requirements

  • Bachelor's degree, Scientific/medical background (B.S./B.A) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy preferred

Experience Requirements

  • Minimum of 3-5 years pharmaceutical experience preferred

Key Competency Requirements

  • 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.
  • 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
  • Experience to supervise a team of individuals successfully and productively
  • 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 influencing them to accomplish common goal
  • Mastery of the intricacies of the BMS drug safety database.
  • Knowledge of BMS drug development and commercialization process and the impact of safety data Processing on that process.
  • Experience working with a wide range of technically and culturally diverse people and influencing them to accomplish a common goal.
  • Technical Proficiency Experienced in advanced functionalities of operational tools. Integrates/utilizes 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 [Confidential Information] . Visit 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.

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