Senior Manager Benefit Risk Assessment operations at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

PharmD/PhD or equivalent with a minimum of 5 years’ experience in Pharmacovigilance/Pharmaceutical Industry or equivalent
Thorough understanding of requirements for complex strategic documents and PBRER (Periodic Benefit-Risk Evaluation Report)
Strong experience in Clinical overview and Clinical documents - protocol, submission

Responsibilities

Attend meetings as part of structured benefit risk assessment (SBRA) to understand approaches and data, and contribute
Schedule meetings to discuss risk management strategy for upcoming authoring of risk management documents
Facilitate meetings with SBRA team, record and distribute meeting minutes, and follow up on action items
Produce a detailed timeline for Core SBRA document and ensure alignment with Clinical overview timelines
Perform project management to ensure timelines are met and follow up on deliverables
Author and edit sections for structured benefit risk assessment based on source documents like clinical study reports (e.g., investigator brochures)
Manage documents related to SBRA for review, adjudicate comments, and facilitate approvals
For various risk management documents (e.g., core additional risk minimization measures or regional), support authoring, formatting, coordination/project management compliant to BMS style guide and core template, outreach to stakeholders for review/approval, and dissemination to local markets
Support communications to local markets or key internal stakeholders on releases of risk management documents and rationale for updates
Understand relationships and dependencies between documents and ensure consistency in information (e.g., in IBs) and alignment of safety messaging across safety risk-related documents
Perform quality review of documents against source documents, ensure internal consistency and high quality
Ensure assigned documents are produced in accordance with relevant internal SOPs, BMS style guide, and core template
Contribute to and participate in internal audits as needed
Support other tasks as assigned

Skills

Benefit Risk Assessment

Structured Benefit Risk Assessment (SBRA)

Risk Management

Drug Safety

Regulatory Submissions

Meeting Facilitation

Document Authoring

Stakeholder Collaboration

Action Item Tracking

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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