Neeraj Shukla
Aggregate Report Writing || PSURs/PBRERs || ROW reports || EU reports || Literature Review || Signal Detection || ICSR || Problem-Solving DMAIC || EU MDR|| Benefit Risk Assessments, similar device report
- Role
- Sr Associate Ii, Medical Writing at Alcon
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Neeraj Shukla
I am a Medical Device and Drug Safety professional with 10+ years of experience in…
Experience
Sr Associate Ii, Medical Writing
Oct 2023 — Present · Bengaluru, IN
Primary author for regulatory safety information required in technical files, including but not limited to post-market surveillance plans, safety narratives, and aggregate reports (e.g, periodic safety update reports) across regions.Gather, organize, and interpret the relevant safety data for assigned projects; interface with other functional subject matter experts to ensure document accuracy, comprehensiveness, quality, and regulatory complianceAddress reviewers’ comments and manage revisions with minimal supervisionSupport the preparation of safety document templates, continuous improvement initiatives, or other department projects for clinical safety or post-market surveillance
Education
Gian Sagar Dental College, Village Ram Nagar, Banur, BFUHS
BDS
2007 — 2012
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