Job Title: Medical Director – Patient Safety Physician
Location: Bangalore, India
Employment Type: Full-Time
Experience Required: 10+ years in Pharmacovigilance/Patient Safety and Clinical Development
Application Deadline: February 20, 2026
Job Requisition ID: R-243649
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company committed to transforming the discovery, development, and delivery of innovative medicines. We operate across multiple therapeutic areas, addressing some of the world’s most complex and life-threatening diseases. Join us to contribute to patient-centered innovation, impact global health, and shape the future of medicines.
As Medical Director – Patient Safety Physician, you will lead patient safety strategy across a diverse global portfolio, ensuring that safety considerations are integrated into every stage of drug development. You will provide strategic clinical guidance, oversee risk management, signal evaluation, and regulatory safety submissions, while mentoring and collaborating with cross-functional teams. This role demands a high level of clinical judgment, strategic insight, and regulatory expertise to safeguard patients and accelerate delivery of life-changing therapies.
Safety Governance & Risk Management:
Review, endorse, and implement Patient Risk Management Plans (PRMPs)
Design and provide strategic clinical input to minimize risks across studies and programs
Ensure patient safety is proactively integrated into clinical development planning
Cross-Functional Leadership:
Represent Patient Safety in Clinical and Project Teams
Facilitate Safety Management and Safety Review Team activities
Align safety requirements across functional documentation to enable efficient delivery
Signal Detection & Evaluation:
Lead end-to-end safety surveillance, evaluating complex safety signals
Direct database searches and information utilization to ensure accurate safety assessment
Translate data into actionable, patient-focused decisions and labeling strategies
Regulatory Reports & Submissions:
Contribute medical input for periodic reports (PBRERs, PSURs, DSURs) and global submissions (NDA, BLA, MAA)
Support safety-related regulatory submissions with precise, robust documentation
Advise on Safety Agreements, licensing arrangements, and regulatory strategy
External Engagement:
Represent Patient Safety in external regulatory and non-regulatory meetings
Collaborate with licensing partners, consultants, and other stakeholders
Continuous Improvement & Mentoring:
Support process improvement initiatives and uphold inspection readiness
Mentor junior team members in signal evaluation, risk management, and safety reporting
Clinical & Safety Expertise: Proven experience in pharmacovigilance, patient safety, and clinical risk management
Regulatory Knowledge: Deep understanding of global drug safety regulations, ICH guidelines, and clinical development requirements
Leadership: Experience leading cross-functional safety teams, Safety Review Teams, and contributing to strategic decisions
Signal Evaluation: Skilled in evaluating complex safety signals and translating them into regulatory and clinical actions
Regulatory Reporting: Experience preparing and reviewing safety documentation for global submissions
Mentoring & Training: Ability to guide junior physicians and safety staff in best practices
Education: Medical degree (MBBS/MD) with specialization or relevant post-graduate training
Experience Required: Minimum 10 years in pharmacovigilance, clinical safety, or patient safety physician roles within the pharmaceutical or biotechnology industry.
Influence global patient safety strategies and impact the development of life-changing medicines
Collaborate with diverse, cross-functional teams and thought leaders in clinical development
Enjoy a culture that values curiosity, bold thinking, and continuous learning
Access modern tools, structured mentoring, and career growth opportunities in a global organization
Contribute to programs that improve patient outcomes and address unmet medical needs
If you are ready to shape patient safety strategy, lead risk management, and accelerate breakthrough medicines, apply now and join AstraZeneca in Bangalore.
Application Deadline: February 20, 2026
AstraZeneca is committed to diversity, equity, and inclusion and welcomes applications from qualified candidates of all backgrounds, ensuring equal opportunity and compliance with all applicable laws
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