Associate Director, Medical Safety Assessment Physician – Hyderabad, India
Employer
Bristol Myers Squibb (BMS)
Location
Hyderabad, Telangana, India – On-site/Hybrid options based on role requirements
Category
Pharmacovigilance / Medical Safety
Job Overview
Bristol Myers Squibb is seeking an experienced Associate Director, Medical Safety Assessment Physician to lead medical safety activities, benefit-risk evaluation, and pharmacovigilance strategy for assigned compounds and programs. The role involves oversight of clinical development, post-marketing safety, and regulatory submissions, serving as the Safety Subject Matter Expert across global and regional operations.
This role provides a unique opportunity to impact patient safety, drive risk management strategies, and contribute to the advancement of innovative therapies in oncology, immunology, and general medicine.
Key Responsibilities
Medical Safety Oversight & Clinical Development
Lead safety assessment and benefit-risk strategies for assigned BMS compounds.
Chair Product Safety Management Teams (SMTs) and provide strategic input to cross-functional teams.
Review and prepare aggregate safety reports (DSUR, PBRER) and clinical trial documents (protocols, IBs, CSRs, IC forms).
Evaluate emerging safety signals from clinical, post-marketing, literature, and real-world data sources; develop strategies for signal management.
Provide safety input for regulatory submissions, product labeling, and risk management plans (RMPs).
Support clinical trial teams with safety-focused protocol review, monitoring, and risk minimization strategies.
Post-Marketing & Regulatory Support
Lead post-marketing safety activities, including aggregate reports, safety studies, and Health Authority queries.
Ensure emerging post-marketing safety data is accurately reflected in product labeling.
Represent WWPS (Worldwide Pharmacovigilance Services) at Health Authority and Data Monitoring Committee meetings.
Cross-Functional & Strategic Contributions
Drive process improvement projects and state-of-the-art PV methodology implementation, including risk-based approaches and advanced analytics.
Mentor and support colleagues, promoting teamwork and positive change.
Provide safety expertise to publications, presentations, and regulatory discussions.
Liaise with internal departments, including Regulatory, R&D, Operations, Legal, and Marketing.
Required Qualifications
Education & Experience
MD or equivalent required.
Postgraduate qualification or experience in Internal Medicine, Immunology, Oncology, or related specialties is preferred.
Minimum 3+ years of pharmacovigilance or relevant pharmaceutical/biomedical experience preferred (Medical, Clinical, Regulatory).
Skills & Competencies
Deep understanding of the drug development lifecycle and pharmacovigilance regulations.
Expertise in signal detection, risk management, and benefit-risk evaluation.
Strong knowledge of clinical trial safety assessment, regulatory requirements, and PV processes.
Ability to manage multiple projects, exercise strong analytical reasoning, and make data-driven decisions.
Excellent verbal and written communication skills, including scientific writing and cross-functional collaboration.
Capability to mentor teams and promote adherence to global safety standards.
What BMS Offers
Opportunities to transform patient lives through innovative therapies.
Competitive salary and total rewards package, including health, retirement, and wellness benefits.
Supportive, collaborative workplace culture fostering career growth and continuous learning.
Flexible work arrangements where applicable, along with professional development opportunities.
Application Information
Interested candidates can apply via BMS Careers and upload their resume for consideration. Bristol Myers Squibb is an Equal Opportunity Employer, committed to diversity, inclusion, and providing reasonable workplace accommodations.
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