Senior Physician, Patient Safety

In this role, you will be responsible for delivering high-quality medical safety reviews and supporting pharmacovigilance activities across clinical and post-marketing programs while ensuring compliance with global regulatory standards.

• Conduct detailed medical review of adverse event cases, including clinical trial, literature, and complex drug-device combination cases.
• Assess seriousness, listedness/expectedness, causality, and clinical relevance of reported safety events.
• Provide medical input into case narratives, coding (MedDRA), and safety documentation to ensure accuracy and consistency.
• Identify, escalate, and resolve case-related issues in collaboration with clients and internal teams.
• Ensure compliance with global drug safety regulations, SOPs, and reporting timelines.
• Support audits, inspections, and bid defense activities as a pharmacovigilance subject matter expert.
• Collaborate with project and functional leads to ensure KPIs and quality standards are consistently met.
• Mentor and guide junior physicians on case evaluation and pharmacovigilance best practices.
• Contribute to process improvements and support cross-functional safety discussions.

Requirements:

The ideal candidate is a medically qualified professional with strong pharmacovigilance expertise, excellent clinical judgment, and the ability to manage complex safety evaluations in a regulated environment.

• MBBS, MD, or equivalent medical qualification from a recognized institution.
• Minimum 3 years of experience in pharmacovigilance or drug safety.
• Strong understanding of clinical medicine, medical terminology, and drug development processes.
• In-depth knowledge of global regulatory frameworks including ICH-GCP, GVP, and related guidelines.
• Experience in medical review of adverse event cases and safety data interpretation.
• Ability to assess clinical relevance of complex medical data and make sound medical judgments.
• Strong communication, presentation, and stakeholder management skills in a matrix environment.
• Experience mentoring or guiding junior medical professionals is preferred.
• High attention to detail with ability to manage multiple priorities effectively.

Benefits:

• Competitive compensation package aligned with experience and expertise
• Opportunity to work on global clinical research and pharmacovigilance programs
• Exposure to diverse therapeutic areas and complex medical safety cases
• Professional development and continuous learning opportunities
• Collaborative, science-driven work environment
• Remote flexibility within India
• Direct impact on patient safety and global healthcare outcomes.