Medical Safety Lead

Novartis India; Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Novartis India is seeking a Pharmacovigilance professional to lead drug safety surveillance and risk assessment across the product life cycle. You will oversee clinical trial safety, post‑marketing programs, and ensure regulatory compliance.

The role involves safety signal detection, medical evaluation of adverse events, and collaboration with global development teams to support regulatory submissions.

Qualifications

• Fluency in written and spoken English is required.
• Experience with clinical trial methodology, regulatory requirements and scientific methods.
• Ability to analyze, interpret and communicate clinical safety data to stakeholders.
• Proven experience contributing to safety reports and regulatory documentation.
• Experience managing clinical safety issues.
• Familiarity with Clinical Trials, Medical Information, Pharmacovigilance, Regulatory Compliance, Risk Management and Safety Science.

Responsibilities

• Oversee the drug safety surveillance program including follow-up risk assessment and relatedness to product on adverse reaction reports.
• Provide safety oversight for clinical trials and post‑marketing programs.
• Support resolution of legal liability and ensure regulatory compliance.
• Deliver safety trend analysis, signal detection and risk management across product life cycle.
• Contribute to regulatory authority responses and safety inquiries.
• Prepare core safety documents and clinical overviews for submissions.
• Provide medical input to aggregate safety reports and regulatory submissions.
• Collaborate across global teams to integrate safety insights.

Skills

English fluency

Clinical Trials

Medical Information

Pharmacovigilance

Regulatory Compliance

Risk Management

Safety Science

Authorship of scientific publications

Job description

ROLE

• – Responsible for the drug surveillance program, including follow‑up risk assessment and relatedness to product on adverse reaction reports
• – Oversight of safety in clinical trials and post‑marketing programs
• – Participate in resolution of legal liability and ensure compliance with governmental regulations
• – Provide trending and safety signal detection and risk management assessment throughout the product life cycle
• – Support safety activities for clinical development teams
• – Monitor clinical safety data, including literature, case reports, and signal detection activities
• – Drive the application of AI‑enabled solutions to simplify and enhance pharmacovigilance processes
• – Conduct medical assessment of individual adverse event cases and ensure accurate evaluation
• – Identify, evaluate, and monitor safety signals using single‑case and aggregate data
• – Contribute to responses for regulatory authorities and healthcare professional safety inquiries
• – Support preparation of core safety documents, including clinical overviews and summary reports
• – Provide medical input to aggregate safety reports and regulatory submissions
• – Collaborate cross‑functionally to integrate safety insights across global development teams
• – Guide adverse event coding, causality assessment, and interpretation of clinical safety data

REQUIREMENTS

• – Fluency in written and spoken English
• – Experience in clinical trial methodology, regulatory requirements, scientific methodology, and statistical principles, including authorship of scientific publications
• – Strong ability to analyze, interpret, and clearly communicate clinical safety data to diverse stakeholders
• – Proven experience contributing to safety reports and regulatory documentation
• – Experience managing clinical safety issues
• – Skills in Clinical Trials, Medical Information, Pharmacovigilance, Regulatory Compliance, Risk Management, and Safety Science