15 March, 2022
Location: Begumpet, Hyderabad
Qualification: Any Life science Background.
Worked as a member in PMO (project management office), prepared monthly reconciliations and compliance
Actively involved in client communications, initiated kick off meetings, project initiation, regular follow-up meetings, prepared meeting slides.
Performed ICSR processing (as QR) of spontaneous and literature cases. Case processing in Argus, Clinevo safety databases and Safety Reporting Portal (SRP).
Triage, duplicate search and case book-in of ICSRs.
Submission of ICSRs via Argus and Clinevo databases to various regulatory authorities using XMLs and E2B transmission (to EMA, MHRA and PvPI etc). Submission of cases to US FDA via SRP.
Downloading EMA obligation reports and processing them in Eudravigilance.
Performed Medical Literature Monitoring (MLM) activities using PubMed, Springer Embase databases.
Performed aggregate reporting (PADERs) and generation of line listings in Argus and Clinevo databases.
To coordinate with MICC team and initiate necessary follow-ups and try to establish data integrity.
Drafted project specific SOPs, SDEA, SLAs and SOW.
interested candidates kindly call on 9154383165call timings 10:00a.m to 06:00p.m (No Calls on Saturdays and Sundays)
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