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

5+ years

Not Disclosed

Hyderabad

10 June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words 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 achieving breakthroughs in cell therapy, this work transforms the lives of patients and the careers of those who do it. You’ll have 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 ensures the safety of our medicines through pharmacovigilance and pharmaco-epidemiology deliverables. This includes single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and compliance with global regulatory requirements.

Position Summary

This global role supports the Worldwide Patient Safety vision by understanding the impact and implications 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. The 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. It requires oversight of productivity, quality, and process optimization, ensuring business continuity for compliance-critical safety data processing to support regulatory obligations.

Position Responsibilities

Ensure effective reporting of ICSRs to all applicable regulatory authorities, business partners, and WWPS customers in accordance with global regulatory requirements and WWPS principles.
Review cases for reportability in the Company Safety Database and complete submissions as required.
Monitor distribution and submission failures, including oversight of the Case Processing team.
Monitor receipt of ICSRs submission acknowledgments.
Escalate technical issues to the Database vendor and support resolution.
Provide input on database releases and support UAT.
Monitor IND/New Drug Application (NDA) License Approvals and protocol approval in the USA.
Review annual IND Reports.
Review SAE Management Plan.
Conduct quality checks of reportability decisions for manual submission.
Perform quality checks of newly implemented distribution rules.
Conduct ad hoc retrospective review of reportability.
Update ICSRs Reporting Requirements in the Global Pharmacovigilance Requirements Repository for USA and EMA.
Review and promptly address submission-related correspondence in the AEP mailbox.
Conduct impact analysis for CAPA/deviations, including manual distributions and reportability assessment, rules investigations.
Collaborate with project teams, business partners, vendors, and colleagues to ensure timely implementation of solutions.
Drive innovation by identifying opportunities to leverage technology and process optimization in collaboration with WWPS sub-functions.
Identify capabilities to enhance the case management organization in alignment with WWPS strategy.
Represent Case Management in PV audits and regulatory inspections, contributing to subsequent CAPAs as needed.
Inspire and motivate peers to pursue excellence and identify methods for innovative process improvement and efficiencies.
Exhibit 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 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 formal education or job experiences.
Demonstrated ability to analyze and interpret complex problems/data from various sources and deliver superior business solutions.
Proven ability to work with technically and culturally diverse people, influencing them to accomplish common goals.
Experience operating in a matrix environment.
Experience working directly with customers, technical experts, and professional staff.
Effective communication skills to diverse audiences at multiple levels within the company through various formats.
Knowledge of BMS development/planning processes and inherent limitations to engage appropriate resources in decision-making.
Understanding of organizational structure, operating culture, effective work styles, and achieving results in a changing environment.
Technical proficiency in advanced functionalities of operational tools and integrating digital automation tools into workflows.
Problem-solving skills for reviewing data flows and leveraging digital tools and methods.
Process management skills to optimize existing processes through incremental improvements and digital enhancements.
Data analysis skills to interpret and visualize data using advanced analytical tools and techniques.
Critical thinking skills to evaluate different options based on evidence and context.
Data management skills to monitor and review data for anomalies and patterns.
Strategic thinking skills to understand the role of digital tools in achieving operational goals.
Decision-making skills to support decisions based on data summaries and defined guidelines.
Change management skills to support digital change initiatives and communicate their benefits.

If you come across a role that intrigues you but doesn’t perfectly align 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 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. 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 employees are required to work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The assigned occupancy type is determined by the role’s nature and responsibilities:

Site-essential roles require 100% onsite presence.
Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite presence.
Field-based and remote-by-design roles require physical travel to visit customers, patients, or business partners and attend meetings.

BMS is committed to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. Applicants can request accommodations during the recruitment process. For accommodations, direct inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.

BMS cares about 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 stay updated with Covid-19 boosters.

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

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

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