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Associate Director, Medical Safety Assessment Physician
Job summary
A global biopharmaceutical company is seeking an experienced Associate Director, Medical Safety Assessment Physician to lead medical safety activities and pharmacovigilance strategies. This role involves overseeing clinical development and regulatory submissions, ensuring patient safety, and driving risk management strategies. The ideal candidate has an MD, at least 3 years of experience in pharmacovigilance, and strong communication skills. The position offers a competitive salary and flexible work arrangements.
Benefits
Qualifications
- Minimum 3+ years of pharmacovigilance or relevant pharmaceutical/biomedical experience preferred.
- Deep understanding of drug development lifecycle and pharmacovigilance regulations.
- Expertise in signal detection, risk management, and benefit-risk evaluation.
Responsibilities
- Lead safety assessment and benefit-risk strategies for assigned BMS compounds.
- Provide safety input for regulatory submissions, product labeling, and risk management plans.
- Drive process improvement projects and implement PV methodology.
Skills
Education
Job Type: Full Time Hybrid 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
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).
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.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.