Director, Medical Safety
Location: Bangalore, India / Kolkata, West Bengal, India
Employment Type: Full Time
Job Overview
The Director, Medical Safety is a senior medical leadership role responsible for providing strategic oversight of medical safety, pharmacovigilance, and medical monitoring activities across clinical development programs. The role ensures patient safety, regulatory compliance, risk management, and scientific integrity throughout the clinical trial lifecycle.
The position requires strong clinical expertise, leadership capabilities, stakeholder management skills, and extensive experience in medical safety within pharmaceutical, biotechnology, CRO, or clinical research environments.
Key Responsibilities
Medical Safety Leadership
Provide strategic medical safety leadership across clinical development programs.
Oversee medical safety and pharmacovigilance activities throughout the product lifecycle.
Ensure patient safety is maintained across all assigned studies and programs.
Support benefit-risk evaluation and safety signal assessment activities.
Provide medical guidance on safety-related matters to internal and external stakeholders.
Medical Monitoring & Clinical Oversight
Review and evaluate safety data from clinical trials.
Monitor adverse events, serious adverse events, and emerging safety concerns.
Assess medical trends and identify potential safety signals.
Provide medical input into protocol development and study conduct.
Support clinical study teams with medical expertise and risk assessments.
Regulatory Compliance & Governance
Ensure compliance with:
ICH-GCP Guidelines
Global Pharmacovigilance Regulations
Local Regulatory Requirements
Sponsor Requirements
Support regulatory submissions and safety reporting activities.
Participate in regulatory inspections, audits, and health authority interactions.
Ensure inspection readiness across assigned programs.
Risk Management & Safety Evaluation
Lead safety review activities and benefit-risk assessments.
Support development and implementation of risk management strategies.
Evaluate safety concerns and recommend appropriate mitigation plans.
Ensure timely escalation and resolution of safety-related issues.
Stakeholder & Client Management
Act as a trusted medical advisor to clients and project teams.
Collaborate with:
Clinical Operations
Pharmacovigilance
Regulatory Affairs
Data Management
Biostatistics
Sponsors and Investigators
Build and maintain strong relationships with clients and key stakeholders.
Leadership & Team Development
Provide leadership, mentorship, and guidance to medical safety teams.
Support professional development of team members.
Contribute to departmental growth and strategic initiatives.
Drive a culture of quality, compliance, and scientific excellence.
Project & Financial Management
Support planning and execution of medical safety deliverables.
Contribute to project strategy and operational planning.
Manage priorities, timelines, and resource allocation effectively.
Support business development and client engagement activities where required.
Continuous Improvement
Identify opportunities to improve medical safety processes and operational efficiency.
Drive implementation of best practices and quality initiatives.
Support innovation and process optimization across safety functions.
Qualifications
Education
Medical Degree (MBBS or equivalent) from an accredited and internationally recognized medical school.
Licensure
Valid medical license (or equivalent) in the country or region of residence and practice.
Experience (Minimum Required)
Minimum 5 years of clinical practice experience after obtaining a medical degree.
OR
Combination of:
Clinical practice experience
Graduate medical training
Pharmaceutical physician experience
Minimum 5 years of experience in:
Medical Safety
Pharmacovigilance
Medical Monitoring
Drug Safety
Clinical Development
Experience within:
Pharmaceutical Companies
Biotechnology Organizations
Clinical Research Organizations (CROs)
Healthcare Research Environments
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