Senior 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 i
