MEDICAL DIRECTOR – PATIENT SAFETY PHYSICIAN
Company: AstraZeneca
Location: India (Hybrid – Minimum 3 Days Office)
Job ID: R-254610
Employment Type: Full Time
Grade: GCL F
JOB OVERVIEW
The Medical Director, Patient Safety Physician is responsible for leading global clinical safety strategy for assigned products throughout development and post-marketing phases. The role focuses on benefit-risk assessment, signal detection, safety surveillance, regulatory submissions, risk management planning, and pharmacovigilance leadership. The position partners with clinical development, regulatory affairs, epidemiology, and medical teams to ensure patient safety while supporting successful drug development and commercialization.
KEY RESPONSIBILITIES
• Clinical Safety Strategy
Lead clinical safety strategy for assigned products across development and post-marketing stages.
Identify safety risks and establish mitigation strategies.
Define safety go/no-go criteria for development programs.
Support Target Product Profile (TPP) and Target Product Claims (TPC) development.
Contribute to overall benefit-risk assessments.
• Risk Management
Develop and oversee Risk Management Plans (RMPs).
Review and approve safety specifications and pharmacovigilance plans.
Implement risk minimization activities globally.
Maintain product Reference Safety Information (RSI).
Ensure effective monitoring of product safety profiles.
• Safety Governance & Leadership
Chair and lead Safety Management Teams (SMTs).
Represent Patient Safety on clinical and project teams.
Participate in urgent safety issue investigations.
Present safety updates to governance committees and investigators.
Provide strategic safety recommendations to senior leadership.
• Clinical Development Support
Provide safety input into clinical development programs.
Review and approve:
Clinical Protocols
Investigator Brochures (IBs)
Informed Consent Forms (ICFs)
Clinical Study Reports (CSRs)
Support Data Monitoring Committees (DMCs).
Define project-specific safety monitoring requirements.
• Signal Detection & Safety Surveillance
Lead signal detection and evaluation activities.
Review Individual Case Safety Reports (ICSRs).
Analyze emerging safety signals and trends.
Direct database searches and safety data reviews.
Coordinate investigations of potential safety concerns.
• Regulatory Affairs & Submissions
Develop safety submission strategies.
Respond to regulatory authority safety questions.
Support NDA, BLA, and MAA submissions.
Participate in regulatory agency interactions.
Prepare labeling updates and safety documentation.
• Aggregate Safety Reporting
Provide medical review and approval of:
PSURs (Periodic Safety Update Reports)
PBRERs (Periodic Benefit-Risk Evaluation Reports)
DSURs (Development Safety Update Reports)
PADERs (Periodic Adverse Drug Experience Reports)
Ensure timely and compliant regulatory reporting.
• Pharmacovigilance System Management
Support the EU Qualified Person for Pharmacovigilance (QPPV) function.
Ensure pharmacovigilance system compliance.
Maintain inspection readiness.
Oversee safety agreements and compliance requirements.
• Cross-Functional Collaboration
Collaborate with:
Clinical Development
Regulatory Affairs
Epidemiology
Medical Affairs
Biostatistics
Informatics Teams
Support licensing and due diligence activities.
Participate in partner and authority meetings.
• Process Improvement & Innovation
Lead pharmacovigilance process improvements.
Utilize safety science and advanced analytics.
Explore informatics, modeling, and simulation approaches.
Implement innovative safety evaluation methodologies.
• Mentoring & Leadership
Mentor junior Patient Safety Physicians.
Train teams on:
Signal Evaluation
Risk Management
Safety Reporting
Foster scientific excellence and collaboration.
EDUCATION
MBBS, MD, or Equivalent Medical Degree
Medical Registration Required
PREFERRED EDUCATION
MD Specialization
MSc
PhD
Advanced Pharmaceutical Medicine Training
EXPERIENCE
Minimum Requirements
2+ Years Clinical Practice Experience (Post Registration)
2+ Years Drug Development and Patient Safety Experience
Majority of industry experience should be within Pharmacovigilance/Patient Safety
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