Associate Director, Patient Safety Scientist
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Company: Bristol Myers Squibb (BMS)
Experience Required: 6–8+ years
Job Category: Patient Safety / Pharmacovigilance / Drug Development
About Bristol Myers Squibb (BMS)
Bristol Myers Squibb offers a dynamic, purpose-driven environment where scientific innovation directly impacts patient lives. The organization supports professional growth through large-scale opportunities, collaborative teams, and a culture of inclusion, flexibility, and continuous development.
Role Overview
The Associate Director, Patient Safety Scientist plays a pivotal role in shaping global safety strategies across the product lifecycle. This position involves leadership in signal detection, risk management, regulatory submissions, and cross-functional collaboration to support clinical development and post-marketing safety surveillance.
This is a senior scientific role requiring deep expertise in pharmacovigilance, safety science, data evaluation, and strategic decision-making.
Key Responsibilities
1. Signal Detection, Evaluation, and Safety Surveillance
Lead core signal detection, review of safety-related literature, and quantitative analysis activities across the product lifecycle.
Conduct and oversee Signal Detection Review Meetings (SDRMs), ensuring scientific accuracy and timely escalation of critical issues.
Drive strategies for signal evaluation including case series, literature review, and assessment using safety databases.
Author comprehensive signal evaluation reports with clear conclusions and recommendations.
Prepare and review safety and risk-management sections of aggregate reports (DSUR, PBRER, PADER).
Support global teams in preparing responses to health authority queries on emerging safety issues.
2. Clinical Development & Study Support
Lead development and review of safety-related content in clinical documents including:
Study protocols
CSRs
Investigator Brochures (including RSI)
Informed Consent Forms
Provide expert safety representation in internal and external meetings such as scientific advice, advisory committees, and data monitoring boards.
3. Regulatory Submissions & Postmarketing Safety
Execute safety strategy for regulatory submissions including MAAs.
Author and review key safety deliverables such as ISS, SCS, briefing documents, safety table shells, and initial product labeling (USPI, CCDS, SmPC).
Prepare responses to regulatory agency safety requests (e.g., 120-day updates).
Support regional and EU QPPV functions as needed.
Contribute to safety labeling updates and benefit-risk assessments.
4. Risk Management & Global Safety Governance
Lead creation, maintenance, and alignment of global and regional Risk Management Plans (RMPs).
Develop and oversee additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs).
Collaborate with Epidemiology on risk minimization effectiveness and post-authorization safety studies.
5. Process Excellence, Audits & Cross-Functional Leadership
Introduce automation and AI-driven improvements to safety processes.
Support audit and inspection readiness through assessment of current PV processes and alignment with regulatory expectations.
Lead or participate in cross-functional initiatives, process harmonization, and updating of procedural documents.
Mentor junior safety scientists and contribute to a high-performance team culture.
Required Qualifications
Education
Scientific degree required: BS, MS, RN, PharmD, PhD, or MD
Advanced scientific or clinical qualifications preferred
Experience
Minimum 6–8 years in pharmacovigilance, clinical development, drug safety, or pharmaceutical industry roles
Proven ability to lead safety strategy, interpret complex data, and make scientifically sound decisions
Experience mentoring and guiding junior team members
Competencies
Strong understanding of safety science, regulatory requirements, and global health authority expectations
Expertise in data analysis, medical evaluation, and risk management
Ability to synthesize complex clinical and post-marketing data
Strong communication, documentation, and cross-functional leadership skills
Ability to integrate automation, digital tools, and AI to enhance safety processes
Work Model
BMS follows an occupancy-based work model. This role is expected to operate under the site-by-design framework, with a minimum 50% on-site presence for optimal collaboration and productivity.
Additional Information
Travel Requirements: Not applicable
BMS supports applicants requiring reasonable accommodations and is an equal opportunity employer.
BMS does not request financial information or payments during recruitment.
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Siliguri |Illinois :
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