p
pharmexa

VIJAY

@pharmexa

Bridging Clinical Care and Global Regulatory Excellence

India
Inglese, Tamil
Alcune informazioni sono riportate in lingua inglese.
Chi sono
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.... Continua a leggere

Competenze

p
pharmexa
VIJAY
offline • 

Consulta i miei servizi

Ricerca e riassunti
I will handle pharmacovigilance and drug safety
A partire da20 USD / progettoMaggiori dettagli

Esperienza lavorativa

IQVIA

Drug Safety Associate

IQVIA • Full time

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.