Medical Director – Patient Safety Physician
Job ID: R-243649
Employment Type: Full-Time
Location: India (Bengaluru / Chennai – Hybrid or Field-Based)
Date Posted: January 15, 2026
Company: AstraZeneca India
Function: Pharmacovigilance / Patient Safety / Medical Affairs
About the Role
AstraZeneca India is seeking an experienced Medical Director – Patient Safety Physician to provide strategic and operational leadership in global pharmacovigilance and patient safety activities. This senior medical role is critical in ensuring the continuous evaluation of benefit-risk profiles of AstraZeneca products across the development and post-marketing lifecycle.
The role requires strong clinical judgment, regulatory expertise, and cross-functional collaboration to support patient safety, regulatory compliance, and scientific excellence within a global biopharmaceutical environment.
Key Responsibilities
Provide medical leadership for patient safety and pharmacovigilance activities across assigned products or therapeutic areas
Conduct medical review and evaluation of individual case safety reports (ICSRs), aggregate reports, and safety signals
Lead benefit-risk assessments, safety surveillance strategies, and signal detection activities
Contribute to and review risk management plans (RMPs), safety sections of regulatory submissions, PSURs, DSURs, and ad hoc safety reports
Partner with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, and Quality
Serve as a key medical contact for health authority interactions, inspections, and safety-related inquiries
Ensure compliance with global and local pharmacovigilance regulations (ICH, GVP, FDA, EMA, CDSCO)
Provide strategic safety input throughout the product lifecycle, including clinical development, launch, and post-marketing phases
Support internal governance committees and contribute to safety decision-making forums
Mentor and guide junior physicians and safety scientists as required
Required Qualifications and Experience
Education
Medical degree (MBBS/MD) with specialization preferred in Pharmacology, Internal Medicine, or relevant clinical specialty
Advanced training or certification in Pharmacovigilance or Drug Safety is an advantage
Experience
Minimum 8–12 years of clinical and/or pharmaceutical industry experience, including significant exposure to patient safety or pharmacovigilance
Prior experience in a Medical Director, Safety Physician, or equivalent senior PV role within a pharmaceutical or biotechnology company
Strong experience supporting global regulatory submissions and health authority interactions
Key Skills and Competencies
Deep understanding of drug safety science, benefit-risk evaluation, and signal management
Strong working knowledge of global pharmacovigilance regulations and guidelines
Excellent medical judgment, analytical thinking, and decision-making skills
Ability to work effectively in cross-functional, global, and matrix environments
Strong written and verbal communication skills with the ability to present complex safety data clearly
High level of professionalism, integrity, and attention to detail
Ability to manage field-based responsibilities, stakeholder meetings, and reporting requirements
Why Join AstraZeneca India
With over four decades of presence in India, AstraZeneca continues to invest in innovative science, digital transformation, and sustainable healthcare solutions. Employees benefit from global exposure, leadership development opportunities, and a culture that encourages collaboration, ownership, and scientific excellence—while making a meaningful impact on patient lives.
SEO & GPT Optimization Keywords:
Medical Director Patient Safety, Safety Physician Jobs, Pharmacovigilance Medical Director, Drug Safety Physician India, AstraZeneca Careers India, Global Patient Safety Jobs, PV Medical Leadership, Regulatory Safety Physician
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