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Sridevi Pasupuleti

@sridevipasupuleti

Pharmacovigilance and labeling specialist at Thermo Fisher Scientific who managed IVDR labeling projects and product change orders.

United States

Message

At Thermo Fisher Scientific, I managed labeling projects and supported IVDR work, including ECO approvals and releases. I prepared specifications for labeling changes, updated documentation for Product Change Orders, and worked with cross-functional teams on compliant product labeling.

Previously, I processed and reviewed clinical and post-marketing safety cases at Halozyme Therapeutics, Inc., Janssen Pharmaceuticals (J&J), Bristol Myers Squibb (BMS), Syneos, and Taro Pharmaceuticals. My work included adverse event assessment, MedDRA coding, case narratives, regulatory reporting, and safety database processing using Argus and ARISg.

Experience

Work history, roles, and key accomplishments

Safety Specialist / Labeling Specialist II

Thermo Fisher Scientific

Jan 2024 - May 2026 (2 years 4 months)

Implemented packaging and labeling strategies for pharmaceutical products, managed labeling projects, and ensured compliance with client specifications and industry regulations.

Labeling Packaging Regulatory Compliance Adobe Acrobat Oracle Document Management Cross Functional Collaboration Project Management

Drug Safety Specialist

Halozyme Therapeutics, Inc.

Jun 2023 - Dec 2023 (6 months)

Ensured clinical and post-marketing adverse event reports were received, tracked, and evaluated, including initial assessment of seriousness and causality. Processed cases in Argus safety database and performed E2B importing and monitoring.

Argus E2B ICSR Management Pharmacovigilance Adverse Event Reporting MedDRA Data Entry Reconciliations

Specialist 3, Drug/Product Safety

Janssen Pharmaceuticals (J&J)

Jul 2021 - May 2023 (1 year 10 months)

Responsible for case processing and quality review of adverse event reports, including post-marketing, SUSARs, and DSURs, ensuring compliance with worldwide safety regulations. Performed quality review of ICSRs and wrote case narratives.

ICSR Management Case Processing MedDRA Narrative Writing Argus Regulatory Compliance Quality Review Training

Clinical Safety Scientist

Bristol Myers Squibb (BMS)

Jul 2019 - Jun 2021 (1 year 11 months)

Monitored safety reports, performed triage and data entry into ARGUS, coded adverse events using MedDRA, and managed case reports to meet regulatory timelines. Handled product complaints and communicated with reporters.

Argus MedDRA Adverse Event Reporting Triage Data Entry Reconciliations Customer Service Pharmacovigilance

Safety Specialist

Syneos

Feb 2017 - Jul 2019 (2 years 5 months)

Performed data entry and case processing for post-marketed and investigational products, including MedDRA coding and follow-up. Conducted SAE reconciliation and prepared quality observation reports.

Data Entry Case Processing MedDRA SAE Reconciliation Regulatory Compliance Quality Assurance Triage

Drug Safety Associate

Taro Pharmaceuticals

Jun 2015 - Feb 2017 (1 year 8 months)

Logged and processed ADR reports into ARISg database, including clinical trial, spontaneous, and literature reports. Performed electronic reporting (E2B) to regulatory authorities and supported PSUR preparation.

ArisG Mapping E2B ADR Pharmacovigilance Regulatory Submissions PSURs Reconciliations