Senior Manager, Patient Safety Scientist
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
About the Role
Bristol Myers Squibb (BMS) is seeking an experienced Senior Manager, Patient Safety Scientist to support global clinical development, safety surveillance, risk management, and regulatory activities across the product life cycle. This role plays a critical part in ensuring patient safety by leading signal detection, safety evaluations, safety strategy execution, and documentation required for global submissions and post-marketing activities.
This position requires strong scientific expertise, advanced pharmacovigilance knowledge, and proven ability to collaborate across cross-functional teams in a global environment.
Key Responsibilities
Signal Detection, Management, and Safety Surveillance
Perform end-to-end signal detection, analysis, and assessment using safety databases, literature monitoring, and quantitative tools.
Lead Safety Data Review Meetings (SDRMs) by evaluating clinical data, identifying safety trends, and escalating emerging concerns.
Develop and execute signal evaluation strategies including case series, literature reviews, and evaluation of external data sources.
Prepare detailed safety signal reports and maintain accurate documentation in the signal management system.
Contribute to safety and risk-management sections of aggregate reports such as DSURs, PBRERs, and PADERs.
Support global markets in preparing responses to regulatory safety queries.
Clinical Development Support
Contribute to the preparation and review of safety sections in clinical documents including protocols, CSRs, IBs, ICFs, and contraception guidance.
Represent Patient Safety during internal and external discussions, advisory meetings, scientific advice interactions, and publications.
Provide safety input for clinical development strategies and benefit-risk assessments.
Submission Planning and Post-Marketing Safety
Support safety strategy for regulatory submissions, including MAA filings, labeling, SCS, ISS, and briefing documents.
Analyze safety data to support labeling updates, ensuring accurate reflection of emerging post-marketing safety information.
Prepare regulatory responses including 120-day safety updates and other post-submission safety deliverables.
Collaborate with EU QPPV and regional safety teams on safety issues affecting assigned products.
Risk Management Planning and Execution
Lead development and maintenance of global and EU Risk Management Plans (RMPs).
Manage creation and updates to Emerging Data Safety Reports (EDSR).
Coordinate risk minimization strategies, including additional RMMs, aPVAs, educational materials, and complex programs such as Pregnancy Prevention Plans.
Work with epidemiology teams on risk-minimization effectiveness evaluations and PASS/NIR activities.
Departmental & Cross-Functional Activities
Utilize automation, digital tools, and AI-generated insights to improve workflows and data analysis.
Support inspection readiness and compliance with evolving global regulatory expectations.
Collaborate across therapeutic areas, ensuring alignment with product strategy, development milestones, and safety governance.
Contribute to process improvements, SOP updates, and cross-functional efficiency initiatives.
Qualifications and Experience Required
Education
Scientific degree such as BS, MS, RN, PharmD, PhD, or MD, or an equivalent combination of relevant education and professional experience.
Experience
Minimum 4–6 years of experience in pharmacovigilance, pharmaceutical industry, or drug development.
Strong working knowledge of medical concepts, global safety regulations, and safety activities across clinical and post-marketing phases.
Experience in preparing safety documents, signal detection, benefit-risk assessment, and regulatory safety submissions.
Ability to analyze complex medical, clinical, and post-marketing data and translate findings into clear scientific documentation.
Familiarity with basic statistics, safety databases, automation tools, and digital platforms used in pharmacovigilance.
Skills
Strong analytical, scientific, and conceptual thinking skills.
Ability to manage timelines, coordinate cross-functional inputs, and ensure high-quality deliverables.
Adaptability and flexibility in managing multiple priorities and shifting regulatory demands.
Excellent written and verbal communication skills for global regulatory interactions.
Work Model
This role follows the BMS on-site protocol. On-site presence may be required based on business needs and collaboration requirements. Specific work model (site-essential, site-by-design, field-based, or remote-by-design) will depend on job responsibilities.
Equal Opportunity and Accessibility
BMS supports an inclusive and accessible hiring process. Reasonable workplace accommodations can be requested at any stage of recruitment.
The company complies with applicable regulations related to equal employment opportunity and candidate rights, including consideration of applicants with arrest or conviction records.
Application Guidance
If this role aligns with your expertise but does not perfectly match your experience, you are encouraged to apply. BMS values diverse skill sets and the potential to grow into transformative career opportunities.
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
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