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Prakash Kumar
Clinical Scientific Expert-II
Clinical Scientific Expert-II
Prakash Kumar is a Clinical Research and Pharmacovigilance professional with 13+ years of experience in clinical data review, safety surveillance, protocol and ICF development, MedDRA coding, and medical writing. He has extensive expertise across clinical trial operations, regulatory compliance (ICH-GCP, FDA, EMA, 21 CFR Part 11), and safety data review. Prakash collaborates with cross-functional global study teams to support protocol development, CSR writing, SAE/ICSR handling, and e-narrative preparation. Known for driving process improvement, ensuring audit-ready documentation, and mentoring new team members, He consistently delivers high-quality clinical and safety deliverables across multiple therapeutic areas.
FORMERLY AT
Novartis
LOCATION
Hyderabad
AVAILABILITY
Full-time
Skills
Argus
Argus 7.1
CIOMS
EDC Platforms
JReview
MedDRA
Oracle Clinical
Rave
RaveX
Regulatory Submissions Tools
SPOTFIRE
WHO-DD
Work Experience
Clinical Scientific Expert-II
Novartis
April 2021 – Present
- Prepare Informed Consent Forms (ICFs) and support protocol development and data review.
- Develop edit check specifications, QTL documents, and perform protocol deviation analysis
- Conduct trend analysis for safety and clinical data (SAE, ConMed, deviations). Create CRFs, DMC safety update packages, and blinded assessor guidance.
- Support CSR writing and e-narrative preparation. Mentor new team members and conduct knowledge-sharing sessions.
TECHNOLOGIES
Oracle Clinical, Rave, Argus 7.1, JReview, Spotfire, RaveX, EDC Platforms
Clinical Scientific Expert-I
Novartis
December 2017 – March 2021
- Performed clinical data review at patient/site/study levels using JReview, Spotfire, and RaveX.
- Managed medical queries, supported interim analyses, and facilitated database locks.
- Performed SAE reconciliation between clinical and safety databases and reviewed SUSAR narratives.
TECHNOLOGIES
JReview, Spotfire, RaveX, Argus, MedDRA, WHO-DD
Junior Safety Submission Expert
Novo Nordisk
October 2016 – November 2017
- Submitted ICSRs to regulatory authorities and business partners.
- Managed CIOMS and E2B XML submissions and coordinated with external vendors.
TECHNOLOGIES
Argus, Regulatory Submissions Tools, CIOMS
