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Senior Manager, Patient Safety Scientist

4-6 years
Not Disclosed
10 Dec. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Manager – Patient Safety Scientist
Location: Hyderabad, Telangana, India
Job Type: Full-Time

Company Overview:
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader dedicated to transforming patients’ lives through science. At BMS, employees engage in meaningful work that spans clinical development, patient safety, and cutting-edge therapeutic innovations. We foster a culture of collaboration, inclusion, and scientific excellence, providing opportunities for professional growth while advancing healthcare globally.

Role Overview:
BMS is seeking a Senior Manager, Patient Safety Scientist to lead pharmacovigilance and patient safety activities across clinical development and post-marketing phases. This role ensures robust signal detection, risk management, and compliance with global safety regulations, supporting the company’s commitment to delivering safe and effective therapies worldwide.

Key Responsibilities:

Signal Detection & Safety Surveillance:

  • Conduct core signal detection, assessment, and management throughout the product lifecycle.

  • Utilize safety databases, literature, and quantitative tools to identify, evaluate, and track safety signals.

  • Author comprehensive signal reports and escalate critical safety issues to the Safety Management Team (SMT).

  • Contribute to aggregate safety reports, including DSUR, PBRER, and PADER, and respond to ad hoc regulatory safety requests.

Clinical Development Product Support:

  • Review and contribute to safety sections of clinical documents, including protocols, CSRs, Investigator Brochures, ICFs, and RSI.

  • Support safety strategy during internal and external meetings, including advisory committees, scientific advice, and pre-submission discussions.

  • Provide safety expertise for early development programs, including product labeling support and trial oversight.

Regulatory Submission & Postmarketing Safety:

  • Implement safety strategies for regulatory filings, including MAA submissions, safety tables, ISS, SCS, and labeling updates.

  • Collaborate with EU QPPV or local QPs on global and local safety requirements.

  • Ensure risk management plans and additional risk minimization measures are maintained and aligned with regulatory and company standards.

Risk Management Planning & Execution:

  • Develop and maintain global and local Risk Management Plans (RMPs) and additional Pharmacovigilance Activities (aPVAs).

  • Coordinate with local markets, vendors, and cross-functional teams for complex risk minimization programs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs).

  • Utilize automation and AI tools to enhance safety surveillance, streamline workflows, and improve data analysis.

Cross-Functional Collaboration & Innovation:

  • Build strong partnerships with SMT, clinical, regulatory, and other stakeholders.

  • Identify opportunities for process improvement, standardization, and digital transformation in patient safety activities.

  • Support preparation for audits, inspections, and regulatory compliance initiatives.

Qualifications & Experience Required:

  • Education: BS, MS, RN, PharmD, PhD, MD, or equivalent with relevant professional experience.

  • Experience: Minimum 4–6 years in pharmacovigilance, patient safety, clinical development, or pharmaceutical industry roles.

  • Strong understanding of medical and safety concepts across clinical and postmarketing settings.

  • Knowledge of global safety regulations, ICH-GCP guidelines, and pharmacovigilance requirements.

  • Excellent analytical, scientific, and conceptual skills, with attention to detail.

  • Ability to manage timelines, cross-functional priorities, and complex projects.

  • Familiarity with AI, digital platforms, and automation tools in safety data management is desirable.

Why Join BMS:

  • Engage in life-changing work that impacts patients globally.

  • Collaborate with high-performing teams across patient safety, clinical, regulatory, and medical functions.

  • Drive innovation in pharmacovigilance through AI, automation, and global safety standards.

  • Access professional growth opportunities, learning programs, and leadership development.

Equal Opportunity & Accessibility:
BMS is committed to inclusion, diversity, and accessibility. We provide reasonable accommodations for candidates with disabilities and ensure equal employment opportunities for all qualified applicants.

Application Process:
Submit your resume online via the BMS careers portal. BMS will never request payments, financial information, or social security numbers during recruitment.