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Medical Director- Patient Safety Physician

Astrazeneca
AstraZeneca
2-16 years
Not Disclosed
Bangalore, India
10 March 3, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Director – Patient Safety Physician

Location: Bangalore, India
Job Type: Full-Time
Job Requisition ID: R-243649
Application Deadline: 30 March 2026
Work Model: Hybrid (Minimum three days per week in office)

Company Overview
AstraZeneca is a global, science-led biopharmaceutical organization focused on the discovery, development, and commercialization of prescription medicines across oncology, cardiovascular, renal, respiratory, immunology, and rare diseases. With a strong global development portfolio, AstraZeneca integrates clinical innovation with rigorous safety governance to deliver medicines that improve patient outcomes worldwide.

Role Overview
AstraZeneca is seeking an experienced Medical Director – Patient Safety Physician to lead clinical safety strategy across a diverse global development portfolio. This leadership role is central to pharmacovigilance, benefit-risk evaluation, signal management, regulatory reporting, and safety governance.

The successful candidate will provide strategic medical direction across the product lifecycle—from early clinical development through global submissions—ensuring robust patient safety oversight, compliance with international regulatory standards, and proactive risk management.

Key Responsibilities

Safety Governance & Risk Management

  • Lead and review core Patient Risk Management Plans (PRMP).

  • Provide strategic safety input into clinical development plans and project-specific safety requirements (PSSR).

  • Represent Patient Safety (PS) in cross-functional clinical and project teams.

  • Review and approve key regulatory and clinical documents including:

    • Investigator Brochures (IB)

    • Clinical Study Protocols

    • Informed Consent Forms (ICF)

    • Clinical Study Reports (CSR)

  • Establish and facilitate Safety Management Teams and Safety Review Teams.

  • Support urgent safety issue resolution and cross-functional investigations.

Signal Detection, Evaluation & Labelling

  • Lead signal detection and medical evaluation activities.

  • Contribute to regulatory labeling updates and Development Core Safety Information (DCSI).

  • Provide medical oversight for database searches and surveillance activities.

  • Collaborate with internal and external stakeholders on signal management and safety review discussions.

  • Support regulatory responses for label deviations and safety queries.

Regulatory Reporting & Submissions

  • Review and provide medical input for periodic safety reports (PBRERs, PSURs, DSURs).

  • Contribute to global regulatory submissions (NDA, BLA, MAA).

  • Support safety components of licensing agreements and due diligence activities.

  • Participate in regulatory authority meetings and inspections.

  • Maintain audit and inspection readiness.

Leadership & Strategic Contribution

  • Mentor junior safety physicians and team members.

  • Drive pharmacovigilance excellence and process improvements.

  • Provide patient benefit-risk assessment leadership.

  • Escalate safety concerns to senior management appropriately.

  • Collaborate in cross-functional and cross-cultural global teams.

Required Experience

  • Total Experience: 16 years overall professional experience.

  • Patient Safety Experience: Up to 11–13 years of pharmacovigilance or patient safety experience with demonstrated leadership delivery.

  • Clinical Experience: Minimum 2 years post-registration clinical practice preferred.

  • Experience in nuclear medicine or Radioligand Therapy is preferred.

  • Strong background in global regulatory requirements for expedited and periodic safety reporting.

  • Proven expertise in signal detection, risk management, benefit-risk assessment, and global safety surveillance.

Educational Qualifications

  • Medical Degree (MD / MBBS or equivalent).

Core Competencies

  • Advanced pharmacovigilance expertise.

  • Deep understanding of global regulatory frameworks (FDA, EMA, ICH guidelines).

  • Strategic leadership and integrative thinking capability.

  • Strong decision-making and accountability mindset.

  • Cross-functional collaboration and stakeholder engagement skills.

  • Excellence in patient benefit-risk assessment.

  • Ability to influence senior leadership and regulatory stakeholders.

Desirable Competencies

  • Conceptual and long-term strategic thinking.

  • Negotiation and influencing skills.

  • Innovation-driven mindset.

  • Business relationship management expertise.

Why Join AstraZeneca?

  • Opportunity to shape global safety strategy for innovative medicines.

  • Exposure to complex development programs across multiple therapeutic areas.

  • Hybrid working model supporting flexibility.

  • Leadership impact on global regulatory submissions and safety governance.

  • Inclusive, diverse, and innovation-focused culture.

SEO & GEO Keywords: Medical Director Patient Safety Jobs India, Pharmacovigilance Leadership Bangalore, Safety Physician Jobs AstraZeneca, Global Drug Safety Careers, Benefit Risk Assessment Roles, Regulatory Safety Reporting India, NDA BLA MAA Submissions, Clinical Safety Strategy Jobs.

This is a high-impact leadership opportunity for experienced pharmacovigilance professionals seeking senior-level patient safety physician roles in Bangalore within a globally recognized biopharmaceutical organization.