Senior Manager – Benefit Risk Assessment Operations
Location: Hyderabad, Telangana, India
Employment Type: Full Time
About the Role
Bristol Myers Squibb is seeking a highly skilled Senior Manager – Benefit Risk Assessment Operations to lead the development, authorship, and refinement of key safety and risk-management documents supporting global regulatory submissions. This role collaborates closely with cross-functional teams to ensure accurate, compliant, and impactful safety information that supports both clinical development and post-marketing risk-minimization strategies.
This position is ideal for experienced pharmacovigilance and drug-safety professionals who excel in scientific writing, risk-management documentation, and cross-functional coordination.
Key Responsibilities
Strategic Authoring and Documentation
Lead the collaborative creation and revision of benefit-risk assessment documents for global regulatory submissions.
Author and edit sections of structured benefit-risk assessments (SBRA) using source materials, including clinical study reports, investigator brochures, and related documentation.
Ensure alignment and consistency across all safety-related documents, including internal and external risk-management materials.
Project Management
Attend SBRA meetings, contribute scientific insights, document meeting minutes, and manage follow-up actions.
Develop detailed timelines for Core SBRA documents aligned with clinical overview schedules.
Coordinate stakeholder reviews, manage document adjudication, and facilitate internal approvals.
Oversee project deliverables to ensure compliance with internal SOPs, BMS style guidelines, and global regulatory expectations.
Risk Management Support
Contribute to the preparation of Risk Management Plans (RMPs), additional risk-minimization measures, and related internal documents.
Support communication with regional and local market teams to disseminate updates and ensure consistent safety messaging.
Quality, Compliance, and Cross-Functional Collaboration
Conduct quality reviews against source documents to ensure accuracy, clarity, and regulatory compliance.
Participate in internal audits as required.
Coordinate multiple projects in a fast-paced, matrix environment with minimal supervision.
Required Qualifications
PharmD, PhD, or equivalent degree.
Minimum 5 years of experience in Pharmacovigilance, Drug Safety, or broader Pharmaceutical Industry functions.
Strong understanding of PBRER, complex safety documents, and regulatory-compliant authoring.
Proven experience in clinical overview documentation and regulatory submission writing.
Ability to analyze complex scientific data and present information clearly to diverse stakeholders.
Preferred Skills
Experience with Risk Management Plans (RMPs) and Clinical Overviews.
Strong collaborative writing capabilities.
Excellent project-management skills, with a track record of meeting strict timelines.
Knowledge of FDA and EMA regulations, GVP Modules V and XVI, ICH guidelines, and Good Clinical Practice standards.
Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
Experience with document-management systems and basic understanding of publishing workflows.
Therapeutic area experience in oncology, hematology, immunology, neurology, cardiovascular, or cell therapy.
Strong interpersonal skills supporting teamwork and cross-functional collaboration.
Why Join Bristol Myers Squibb
At BMS, you will engage in meaningful work that impacts patient lives worldwide. The company provides a culture that supports growth, innovation, and global scientific excellence. Employees benefit from competitive compensation, flexible work arrangements, and access to strong professional-development resources.
On-Site Work Expectations
Work location and on-site requirements may fall under:
Site-Essential (100% onsite),
Site-by-Design (hybrid with minimum 50% onsite),
Field-Based, or
Remote-by-Design.
Onsite presence is essential for fostering collaboration, innovation, and productivity.
Equal Opportunity & Accessibility
BMS ensures a fair recruitment process and provides reasonable accommodations for applicants with disabilities. Qualified applicants with arrest or conviction records will be considered in line with local regulations.
Application Encouragement
If the position resonates with your experience and aspiration—even if your profile does not match every requirement—you are encouraged to apply. Your next career-defining opportunity may be here.
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