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