Medical Director- Patient Safety Physician

Role & Responsibilities

• Lead clinical safety strategy across global drug development programs
• Review and endorse Patient Risk Management Plans (PRMPs)
• Drive proactive risk minimization strategies throughout product lifecycle
• Represent Patient Safety on Clinical, Project, and Safety Management Teams
• Lead safety surveillance, signal detection, evaluation, and labelling strategy
• Provide strategic medical safety input into clinical development planning
• Review and approve safety-related clinical documents (protocols, IBs, ICFs, study reports)
• Provide medical input to periodic safety reports (PSURs, PBRERs, DSURs)
• Contribute patient safety content to global regulatory submissions (NDA, BLA, MAA)
• Respond to regulatory safety queries and label deviation requests
• Collaborate with external partners, vendors, and licensing partners
• Support safety agreements, licensing arrangements, and due diligence activities
• Maintain inspection readiness and ensure compliance with global PV regulations
• Mentor and guide junior safety physicians and team members
• Escalate critical safety issues to senior leadership with integrity and clarity

Qualification

• MD / MBBS with relevant specialty
• Board-certified / residency-trained physician

Experience

• Extensive experience in Patient Safety / Pharmacovigilance
• Strong background in clinical development and regulatory safety
• Experience leading safety strategy for global development programs

Skills

• Deep expertise in global pharmacovigilance regulations and processes
• Strong signal detection, risk management, and benefit–risk assessment skills
• Excellent strategic thinking and clinical judgment
• Proven cross-functional leadership and stakeholder management
• Strong regulatory writing and safety documentation skills
• Ability to influence senior stakeholders and external regulators
• Excellent communication and decision-making skills

About Company

• AstraZeneca is a global, science-led biopharmaceutical company , Focused on transforming patient outcomes through innovative medicines

Closing Date: 19 Feb 2026