p
pharmexa

VIJAY

@pharmexa

Bridging Clinical Care and Global Regulatory Excellence

India
Engels, Tamil
Sommige informatie wordt in het Engels weergegeven.
Over mij
I am a Pharmacovigilance Specialist & Dental Surgeon (BDS) with an M.Sc. in Clinical Drug Development from UCL. With 5.5+ years of experience across global life sciences organizations (including IQVIA), I specialize in end-to-end ICSR case processing, MedDRA coding, and safety data triage. I author fully compliant aggregate safety reports (PSUR, RMP) and regulatory filings (IND, CTA) in strict alignment with CDSCO, USFDA, EMA, and ICH-GCP standards. Proficient in Argus Safety, I deliver 100% compliant medical writing, audit readiness, and safety surveillance.... Lees meer

Skills

p
pharmexa
VIJAY
offline • 

Bekijk mijn diensten

Onderzoek en samenvattingen
I will handle pharmacovigilance and drug safety
VanafUS$ 20 / projectMeer informatie

Werkervaring

IQVIA

Drug Safety Associate

IQVIA • Fulltime

Jan 2021 - Sep 2021 • 8 mos

Managed systematic processing of high-volume Adverse Event (AE) reports within the Argus Safety database. Handled diverse workflows including Spontaneous Reports, E2B electronic submissions, and License Partner reports. Performed medical terminology mapping and coding of adverse events and medical history using international dictionaries.