Bhumika N M
Aggregate Report Writer at Accenture
- Role
- Junior Aggregate Report Safety Scientist at Accenture
- Location
- Mysuru, KA, IN
- LinkedIn followers
- 500 followers
About Bhumika N M
As a author and quality review:• Involved in creation of Aggregate Safety Reports (ASRs) i.e, PBRER, PADER, AdCO, and HA reports.• Conducting kick off meeting with the contributors for the concerned products for which aggregate safety reports need to be prepared.• Review of the source data received from the different contributors which include regulatory, clinical, patient exposure, epidemiology, non-clinical etc, and reverting in case of any discrepancies.• Review of the line listings and summary tabulations from the contributors and inclusion in relevant appendices of the safety report.• Identify or select the literature articles from the hits and review of the selected articles for the inclusion in safety reports after summarizing the article.• Compile the safety data into relevant sections of the reports after proper case bucketing.• Analyzing the cases and presenting the data in the relevant sections of safety reports and reporting if any trend identified in the cases.• Abiding to the timelines agreed during the kick-off meeting with the contributors.• Create all documents in accordance with all applicable SOPs and conventions followed by the company.• Sending the reports to all contributors for review and conducting the comments resolution meeting.• Implementing or updating the report based on the comments/changes suggested by the contributors.• Finalizing the report by providing word and PDF versions of the final documents to the regulatory team.• Responsible / assisted in preparation of responses to Regulatory Authority questions related to safety issues within respect of timelines.• Participate in internal and external audits and inspections by company.
Experience
Junior Aggregate Report Safety Scientist
Dec 2025 — Present · Bengaluru, IN
Education
JSS Academy of Higher Education & Research
Bachelor of Pharmacy - BPharm
JSS Academy of Higher Education & Research
Mpharm, Regulator affairs
JSS Academy of Higher Education & Research
Pg diploma , Regulatory toxicology
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