Role Summary:
Clinical Safety & Pharmacovigilance will provide strategic and operational leadership across pharmacovigilance and clinical safety activities for clinical trial and post-authorization products. This role is responsible for end-to-end oversight of safety surveillance, medical review, signal management, aggregate reporting, compliance, quality, and team leadership, ensuring adherence to global regulatory requirements, client agreements, and industry best practices.

Key Responsibilities:

1. Strategic & Operational Leadership
• Provide overall leadership and ownership of assigned pharmacovigilance and clinical safety projects.
• Ensure effective planning, execution, and delivery of PV activities in line with client agreements, timelines, and quality expectations.
• Act as a senior medical and scientific authority for safety-related decisions across products and therapeutic areas.
• Support organizational growth by identifying process improvements, efficiencies, and best practices within pharmacovigilance operations.

2. Medical Review & Safety Assessment




• Conduct and oversee medical review and assessment of Individual Case Safety Reports (ICSRs) from clinical trials and post-authorization sources.
• Determine case reportability, seriousness, expectedness, and causality/relatedness.
• Review case narratives, source documents, adverse event selection, and MedDRA coding to ensure medical accuracy and regulatory compliance.
• Perform medical and scientific evaluation of safety data including ICSRs, signal reports, aggregate reports, and other safety information.

3. Signal Management & Risk Management
• Lead and oversee signal detection, evaluation, and management activities for innovator and marketed products.
• Implement and review signal detection methodologies in accordance with regulatory guidance.
• Contribute to clinical safety strategy, risk management planning, and benefit–risk assessments.
• Support ongoing safety surveillance and proactive risk i

📌 Director/ Senior Director (India)
🏢 Soterius
📍 India