Lead - Drug Safety Physician-Aggregate Reporting (MR-MBBS)

Job description

Lead Drug Safety Physician – Aggregate Reporting (MBBS/MD) About the Role We are seeking an experienced and detail-oriented Senior Drug Safety Physician with strong expertise in Aggregate Safety Reporting to join our Pharmacovigilance team. The ideal candidate will be responsible for end-to-end authoring, review, and quality control of aggregate safety reports while ensuring compliance with global regulatory requirements and client standards. Key Responsibilities • Lead the preparation, review, and quality control of aggregate safety reports and regulatory documents, ensuring accuracy, quality, and timely delivery. • Manage the complete document lifecycle, including planning, authoring, stakeholder reviews, comment resolution, QC, finalization, and submission readiness. • Author and review complex pharmacovigilance deliverables, including: • PBRERs/PSURs • DSURs • PADERs/PAERs • SUSAR Reports • Risk Management Plans (RMPs) • Addendum Clinical Overviews (ACOs) • Ad-hoc regulatory and safety reports • Perform comprehensive data validation and consistency checks against source documents and reference materials. • Conduct quality control reviews for scientific accuracy, data integrity, consistency, regulatory compliance, formatting, grammar, and adherence to client-specific style guides. • Coordinate with cross-functional stakeholders, safety physicians, clinical teams, and regulatory experts to ensure high-quality deliverables. • Facilitate review cycles, comment reconciliation meetings, and document approval workflows. • Ensure compliance with global regulatory requirements, including FDA, ICH, GCP, and pharmacovigilance guidelines. • Mentor junior team members and provide guidance on scientific writing, document structure, and regulatory expectations. • Support process improvement initiatives aimed at enhancing quality, reducing cycle times, and increasing operational efficiency. • Create and deliver training materials, conduct knowledge-sharing sessions, and contribute to team capability development. • Perform document publishing and formatting activities, including hyperlinking, bookmarking, cross-referencing, pagination, and PDF finalization as required. • Participate in client interactions and contribute to maintaining strong client relationships. Required Qualifications • MBBS (Mandatory) with MCI registration • 3–6 years of hands-on experience in Aggregate Safety Report authoring and review within Pharmacovigilance. • Proven expertise in reviewing and quality-controlling aggregate safety reports, including PBRERs/PSURs, DSURs, PADERs/PAERs, RMPs, ACOs, SUSARs, and other regulatory safety documents. • Strong understanding of global pharmacovigilance regulations, FDA, ICH guidelines, and GCP standards. • Experience in end-to-end document lifecycle management, stakeholder coordination, review comment resolution, and submission readiness activities. • Excellent scientific writing, analytical, and communication skills. • Experience working in a client-facing environment and collaborating with global stakeholders. • Proficiency in Microsoft Office and document publishing tools (Adobe Acrobat and related publishing applications preferred).  Preferred Skills • Strong attention to detail and quality mindset. • Ability to manage multiple projects and competing priorities. • Excellent stakeholder management and mentoring capabilities. • Continuous Learning