p
pharmexa

VIJAY

@pharmexa

Bridging Clinical Care and Global Regulatory Excellence

Inde
Anglais, Tamoul
Certaines informations sont présentées en anglais.
À propos de moi
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.... Plus d’infos

Compétences

p
pharmexa
VIJAY
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Voir mes services

Recherches et comptes rendus
I will handle pharmacovigilance and drug safety
De20 $US / projetPlus de détails

Expérience professionnelle

IQVIA

Drug Safety Associate

IQVIA • Temps plein

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.