Director, Medical Safety Assessment Physician 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

Pharmaceutical, BiotechnologyIndustries

Requirements

Medical degree (MD or equivalent) with expertise in pharmacovigilance and safety assessment
Experience leading safety activities, benefit-risk strategies, and chairing Safety Management Teams (SMTs)
Ability to oversee, prepare, and/or review aggregate safety review documents (e.g., DSUR, PBRER) and safety sections of clinical trial documents (e.g., protocols, CSR, IB, ICF) and regulatory filings (e.g., CTA, MAA)
Expertise in evaluating and managing safety signals from various data sources (e.g., case-series, literature, HA/claims databases)
Knowledge of safety labeling activities, regulatory product labeling, and cross-functional labeling team participation
Experience supporting Qualified Person for Pharmacovigilance (QPPV) and regional PV roles
Familiarity with R&D publication strategies and providing safety input to publications/presentations
Ability to represent at Health Authority (HA) and Data Monitoring Committee (DMC) meetings
Skills in process improvement, developing PV processes/procedures, and mentoring teams
Commitment to efficiency, quality, accuracy, timeliness, global regulatory compliance, and BMS cost-effectiveness goals

Responsibilities

Lead safety activities and benefit-risk strategies for assigned BMS compounds/programs and chair product Safety Management Team(s)
Oversee, prepare, and/or review aggregate safety review documents and safety sections of clinical trial documents and regulatory filings
Lead team in evaluation and management of signals from any data source; develop signal evaluation strategy and document outcomes (e.g., Safety Topic Review/Signal Report)
Lead safety labeling activities for assigned products/programs; act as Safety Subject Matter Expert for regulatory labeling; participate in cross-functional labeling meetings and provide regional support
Lead process improvement projects; assist MSA Therapeutic Area Head/Lead in developing/maintaining PV processes and procedures
Support EU QPPV or other regional/local Qualified Person for PV on assigned product issues
Provide input to R&D publication strategy/plan and ensure safety input to publications/presentations
Drive safety strategy preparation and represent WWPS at HA and DMC meetings
Act as global safety lead for assigned compounds in development; provide support for global submission documents and review draft summaries
Promote collegiality, teamwork, and mentor/support colleagues as a positive change agent
Ensure all tasks are performed efficiently, with quality, accuracy, timeliness, in accordance with global regulations and BMS goals

Skills

Pharmacovigilance

Safety Assessment

Benefit-Risk Strategy

Signal Detection

Safety Labeling

Regulatory Filings

Clinical Trial Safety

Aggregate Safety Reports

Process Improvement

Qualified Person for PV

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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