Director-Clinical Safety & Pharmacovigilance (Noida)

Role Summary: Director - 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 benefitrisk assessments. - Support ongoing safety surveillance and proactive risk identification across the product lifecycle. 4. Aggregate Reporting & Regulatory Deliverables - Oversee and provide medical review for aggregate safety reports, including DSURs, PSURs/PBRERs, and other regulatory submissions. - Ensure timely preparation, high-quality medical content, and compliance with global regulatory requirements. - Collaborate with cross-functional stakeholders to support regulatory submissions and responses. 5. Quality, Compliance & Documentation - Ensure compliance with applicable global regulations, guidelines, internal SOPs, and client-specific processes. - Maintain oversight of quality, compliance, and documentation across all assigned PV projects. - Author, review, and approve SOPs, work instructions, and other functional documents as assigned. - Represent the function during internal audits, client audits, and regulatory inspections. 6. Project & Stakeholder Management - Oversee project management activities, including workload planning, prioritization, and issue resolution. - Communicate effectively with internal and external stakeholders, including clients, vendors, and cross-functional teams. - Monitor project risks and escalate concerns related to quality, resourcing, or timelines to functional leadership. 7. People Leadership & Talent Development - Provide line management and leadership to assigned team members. - Guide, mentor, and develop team members to ensure high performance and professional growth. - Identify training needs and support ongoing learning and capability building within the function. - Monitor team workload and capacity, proactively addressing resourcing or performance challenges. 8. Additional Responsibilities - Perform other pharmacovigilance and clinical safety activities as assigned to meet evolving organizational and client needs. Qualifications & Experience - Medical Degree (MBBS/MD required). - 15+ years of progressive experience in pharmacovigilance and clinical safety, including: - Medical review of ICSRs (SAEs in clinical trials and post-marketing) - Signal detection and signal management - Preparation and medical review of DSURs, PSURs/PBRERs - Experience working with innovator molecules and across multiple therapeutic areas. - Robust knowledge of global pharmacovigilance regulations and guidelines. - Demonstrated leadership experience with strong decision-making and stakeholder management skills. - Excellent written and verbal communication skills. .