Job Title: Director, Medical Safety Assessment Physician
Job Location: Hyderabad, Telangana, India
Company Overview
Bristol Myers Squibb (BMS) is a global biopharmaceutical company that focuses on discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Working at BMS involves transformative work that aims to improve the lives of patients and support high-achieving teams with numerous career development opportunities.
Role Summary
The Director, Medical Safety Assessment Physician leads safety activities and benefit-risk strategies for assigned BMS compounds and programs. This role involves overseeing the safety management process, preparing and reviewing safety documents, and managing safety signals for products. The Director will lead teams in assessing emerging safety concerns and provide input on regulatory product labeling, clinical development, and post-marketing safety activities.
Key Responsibilities
General Product Support
Lead safety activities and benefit-risk strategies for BMS compounds.
Oversee, prepare, and review safety review documents and regulatory filings.
Lead safety signal management and develop strategies for signal evaluation.
Lead safety labeling activities for assigned products.
Support Qualified Person for Pharmacovigilance (PV) for assigned products.
Provide safety input to R&D publication strategy and regulatory submissions.
Clinical Development
Serve as the global safety lead for assigned compounds in clinical development.
Provide safety input to clinical development plans, study protocols, and regulatory documents.
Lead development of safety risk management strategies and support pre-filing activities.
Review and support regulatory responses related to safety.
Post-marketing Support
Lead safety activities for marketed compounds and provide post-marketing safety support.
Evaluate and manage safety signals for marketed products.
Oversee safety risk management activities, including Risk Management Plans (RMP).
Department and Cross-Functional Activities
Lead process improvement projects and support preparation for regulatory inspections.
Liaise with internal teams, including Legal, BD, Operations, and Marketing.
Provide safety training to BMS employees and act as the liaison for product safety.
Required Qualifications
Education: MD or equivalent required. Postgraduate qualification in internal medicine, immunology, oncology, or related specialty preferred.
Experience: 3+ years in Pharmacovigilance or relevant pharmaceutical or biomedical fields.
Skills:
Strong understanding of the drug development process.
Ability to apply pharmacovigilance knowledge to safety concerns and risk minimization.
Proficient in safety assessment and management tools.
Excellent communication and leadership skills.
Travel
Not specified.
Work Environment
BMS offers a flexible work environment with various competitive benefits. The role is likely hybrid or onsite, based on company policy.
How to Apply
Candidates can apply through the Bristol Myers Squibb career page or job portal.
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