Aishwarya Surampuri
Global Labelling Specialist
- Role
- Global Labeling Specialist at Sandoz
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
Experience
Global Labeling Specialist
Sep 2024 — Present · Hyderabad, IN
Text authoring Gap analysis between originator and generic labels, authoring the updates to the required labelling documents and providing the necessary supporting documents in the labeling package. PSUR & Addendum statement Report SubmissionCompile and submit regulatory inputs for Periodic Safety Update Reports (PSURs) and Addendum Statement (AS), ensuring accuracy and regulatory compliance.3. Core Data Sheet DispatchCoordinate its distribution across all global affiliates and markets via Veeva Vault. Signal Detection & EvaluationIdentify and assess safety signals from diverse sources—such as reference product data, literature, and communications with regulatory authorities—and evaluate their potential impact on patient safety.5. Vendor Management*Oversee and manage vendor services (for instance, through TransPerfect), ensuring timely deliverables and adherence to contractual obligations.6. Compliance ReportingDevelop compliance reports specific to the national product portfolio and distribute finalized reports to international partners using Excel-based templates and trackers.
Education
Jamia Hamdard
Bachelor of Pharmacy
2014 — 2018
Jamia Hamdard
Post Graduate diploma
2019 — 2020
Manipal Academy of Higher Education
Master of Pharmacy
2018 — 2020
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