Divya Sattiraju
United States
Summary
Pharmacovigilance / Regulatory Affairs professional with 6+ years of experience supporting clinical and post-marketing safety operations within pharmaceutical and CRO environments. Expertise in ICSR processing, vendor oversight, QC of SAE and non-serious AE cases, Argus Safety, MedDRA coding, safety reconciliations, and global regulatory compliance.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Global Labeling Specialist (Regulatory Affairs)
Sandoz
01.2022 - 01.2025
- Maintained inspection-ready regulatory and safety-related documentation within electronic document management systems (SharePoint/TMF-equivalent).
- Supported cross-functional collaboration between Regulatory, Safety, and Clinical teams to ensure timely availability of approved safety documentation.
- Assisted with audit readiness activities, including document tracking, version control, and archival in compliance with FDA and ICH guidelines.
Drug Safety Associate
PPD
01.2021 - 01.2022
- Processed 20–30 Individual Case Safety Reports (ICSRs) per day for clinical and post-marketing studies in compliance with global regulatory timelines.
- Performed end-to-end ICSR workflow including case triage, data entry, MedDRA coding review, narrative review, and sponsor query resolution.
- Conducted QC of SAE and non-serious AE cases as part of vendor oversight activities to ensure accuracy and regulatory compliance.
- Monitored case processing and reporting within the Argus Safety Database in alignment with SOPs and health authority requirements.
- Assisted with FDA audit preparation by maintaining inspection-ready safety documentation and supporting data verification activities.
Student Intern
RVM Institute of Medical Sciences
01.2018 - 01.2020
- Supported clinical documentation, patient data collection, and record maintenance under protocol-driven environments.
- Assisted with adverse event documentation and clinical compliance activities in alignment with GCP principles.
Education
Doctor of Pharmacy (PharmD) -
JNTUH College of Pharmaceutical Sciences
08-2020
Skills
- ICSR Processing (Clinical & Post-Marketing)
- SAE/AE Case Triage
- Data Entry & Narrative Review
- MedDRA Coding
- Argus Safety Database
- Safety Reconciliations (EDC/IST/Vendor)
- Safety Report Distribution
- FDA Audit Support
- ICH-GCP
- GVP
- FDA
- EMA Regulations
Certification
- Master Program in Pharmaceutical Regulatory Affairs (FDA / EMA / Global)
- Mastering 510(k) Submission Process – RAPS
- Introduction to GCP Guidelines – Novartis
- Drug Development – University of California, San Diego
SYSTEMS & REGULATORY KNOWLEDGE
- Oracle Argus Safety
- EDC Systems
- Electronic Document Management Systems (TMF/eDOCS/SharePoint)
- ICH-GCP
- GVP
- FDA
- EMA Regulations
Timeline
Global Labeling Specialist (Regulatory Affairs)
Sandoz
01.2022 - 01.2025
Drug Safety Associate
PPD
01.2021 - 01.2022
Student Intern
RVM Institute of Medical Sciences
01.2018 - 01.2020
Doctor of Pharmacy (PharmD) -
JNTUH College of Pharmaceutical Sciences