Lead Drug Safety Physician – Aggregate Reporting (MBBS/MD)

About the Role

We are seeking an experienced and detail-oriented Senior Drug Safety Physician with solid 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 cont

📌 Lead - Drug Safety Physician-Aggregate Reporting (MR-MBBS) (Mumbai)
🏢 Indegene
📍 Mumbai