Associate Director – Patient Safety Scientist
Bristol Myers Squibb (BMS) | Hyderabad, India
Experience Required: 6–8 years in Pharmacovigilance / Drug Safety / Pharmaceutical Development
Salary Range: Competitive industry compensation; commensurate with experience
About the Role
Bristol Myers Squibb (BMS) is seeking an accomplished Associate Director, Patient Safety Scientist to lead global safety strategy, signal detection, risk management, and regulatory safety activities across the product lifecycle. This leadership role drives scientific excellence and supports data-driven safety decisions for marketed and investigational products.
As part of BMS, you will work at the forefront of patient safety science while contributing to a global organization committed to transforming patients’ lives through science.
Key Responsibilities
1. Signal Detection, Safety Surveillance & Risk Assessment
Lead signal detection and assessment activities across the product lifecycle.
Conduct evaluation of safety data from clinical trials, post-marketing sources, literature, and quantitative tools.
Drive strategy for signal evaluation, author signal assessment reports, and ensure timely documentation in safety systems.
Review and escalate safety concerns impacting key milestones and cross-functional team decisions.
Provide medical writing support for DSURs, PBRERs, PADERs, and other aggregate safety documents.
Support global and local health authority responses, including risk-management-related queries.
Mentor and guide junior safety scientists in signal interpretation and documentation.
2. Clinical Development Safety Support
Lead the preparation and review of safety sections in protocols, CSRs, IBs (including RSI), ICFs, and contraception guidance.
Represent Patient Safety in internal and external meetings including scientific advisory boards, regulatory interactions, DMECs, and submissions.
Provide strategic input on safety strategy for ongoing and planned clinical development programs.
3. Regulatory Strategy & Post-Marketing Support
Contribute to safety strategy for regulatory filings, including safety messaging and risk mitigation approaches.
Author safety sections of MAAs, briefing documents, ISS/SCS sections, and labeling updates (USPI, CCDS, SmPC).
Respond to health authority safety requests and 120-day updates by synthesizing new safety information.
Support EU QPPV or local QPs in ongoing safety matters.
4. Risk Management Planning & Execution
Develop and update EDSRs, RMPs, and structured benefit-risk frameworks.
Lead creation and maintenance of additional Risk Minimization Measures (aRMMs) and Pharmacovigilance Activities (aPVAs).
Guide global and regional teams on implementation of complex aRMMs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs).
5. Process Excellence & Innovation
Integrate automation, digital tools, and AI solutions into safety workflows to improve efficiency and compliance.
Support preparation for audits and inspections, ensuring alignment with global regulatory expectations.
Contribute to continuous improvement initiatives and update of procedural documents.
Promote a collaborative, high-performance culture across Patient Safety and cross-functional teams.
Qualifications & Experience
Scientific degree: BS/MS/PharmD/PhD/MD/RN or equivalent.
Minimum 6–8 years of relevant experience in pharmacovigilance, safety science, or pharmaceutical development.
Proven experience in signal management, safety strategy, and authoring regulatory safety documents.
Strong understanding of global health authority regulations, drug development milestones, and safety science principles.
Ability to synthesize complex data to support risk-benefit evaluations and influence stakeholders.
Excellent communication, scientific writing, organizational, and leadership skills.
Experience in digital tools, automation, data interpretation, and safety analytics preferred.
Work Model
This position follows the BMS onsite protocol, classified under on-site or site-by-design categories depending on business needs. Onsite presence is essential for collaboration, productivity, and alignment with BMS culture.
Why Join BMS
Bristol Myers Squibb offers:
A high-impact scientific role with global visibility.
Opportunities to work on transformative therapies across oncology, immunology, and cell therapy.
A culture that values innovation, inclusion, accountability, and scientific rigor.
Competitive compensation, employee benefits, flexibility programs, and long-term career development pathways.
Equal Opportunity Commitment
BMS ensures equal employment opportunities for all, including applicants with disabilities, and provides reasonable accommodations during the recruitment process.
How to Apply
Candidates can apply directly through the BMS careers portal.
This role is ideal for experienced safety scientists ready to contribute to global safety strategy and scientific leadership.
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