Open To Work
Divya Sattiraju
Summary
Clinical research professional with 6+ years of experience in clinical research, pharmacovigilance, and regulatory affairs within pharmaceutical and CRO environments. Experienced in clinical trial oversight, safety monitoring, regulatory documentation, and protocol compliance in accordance with ICH-GCP, FDA, and global regulatory guidelines. Proven ability to support site management, clinical data review, investigator coordination, and inspection-ready trial documentation. Skilled in collaborating with sponsors, CRO teams, and clinical sites to ensure high-quality data integrity, patient safety, and efficient study execution.
Overview
1
1
Certification
Work History
Regulatory Affairs Specialist /Clinical Documentation Specialist
Sandoz
2021 - 2025
- Supported clinical development and regulatory documentation activities ensuring compliance with FDA, EMA, and ICH guidelines.
- Reviewed and validated clinical and regulatory documentation for 20+ pharmaceutical products, supporting trial readiness and regulatory submissions.
- Collaborated with clinical research, pharmacovigilance, and regulatory teams to ensure protocol compliance and safety information accuracy.
- Conducted systematic review of safety updates, labeling changes, and regulatory documentation supporting ongoing clinical programs.
- Maintained high-accuracy documentation (>98% compliance) ensuring inspection-ready records and regulatory audit readiness.
- Contributed to cross-functional coordination between clinical operations, safety teams, and regulatory groups to support trial execution.
Drug Safety Associate / Medical Documentation Specialist
PPD (Thermo Fisher Scientific)
2020 - 2021
- Processed and reviewed 300+ Individual Case Safety Reports (ICSRs) supporting safety monitoring in clinical trials.
- Evaluated adverse events, drug interactions, and safety signals in compliance with global pharmacovigilance regulations.
- Collaborated with clinical operations and investigators to resolve safety queries and maintain patient safety oversight.
- Maintained audit-ready safety documentation supporting regulatory inspections and clinical trial monitoring activities.
- Supported clinical teams in ensuring accurate safety reporting and protocol adherence.
Clinical Research Intern
RVM Institute of Medical Sciences
2017 - 2019
- Assisted investigators in protocol-driven clinical research studies involving 50+ patients.
- Supported site coordination, patient recruitment, informed consent, and clinical data collection.
- Maintained Case Report Forms (CRFs), investigator site files, and study documentation in accordance with ICH-GCP standards.
- Coordinated with investigators and site staff to support smooth clinical trial conduct and documentation accuracy.
Education
Doctor of Pharmacy - PharmD
Skills
Clinical trial monitoring
Protocol compliance oversight
Investigator and site coordination
Clinical data review and resolution
Case report form validation
Adverse event monitoring
Pharmacovigilance processing
MedDRA coding and narrative review
Drug safety evaluation
Regulatory documentation assessment
Trial start-up and ethics submissions
TMF and eTMF management
Inspection-ready documentation
ICH-GCP compliance
FDA and global regulations
Clinical study documentation management
Cross-functional collaboration with regulatory and safety teams
Systems and Tools:
Oracle Argus Safety Database
Veeva Vault
SAP
TVT Tools
eCTD Documentation Frameworks
Certification
- Mastering 510(k) Submission Process - RAPS
- ICH-GCP Certified
- Master Program in Pharmaceutical Regulatory Affairs (Global)
Work Preference
Job Search Status
Open to workWork Type
Full TimePart TimeContract WorkLocation Preference
RemoteSalary Range
$40/hr - $45/hrTimeline
Regulatory Affairs Specialist /Clinical Documentation Specialist
Sandoz
2021 - 2025
Drug Safety Associate / Medical Documentation Specialist
PPD (Thermo Fisher Scientific)
2020 - 2021
Clinical Research Intern
RVM Institute of Medical Sciences
2017 - 2019