pratik's Profile is not available for public view.
"I Rock! Myself Pratik Vikash Singh"
Job Title: Pharmacovigilance Associate
Company/School: Symogen Limited
Location: New Delhi, NCT, India
An enthusiastic and high energy driven professional seeking positions and challenging assignments in Pharmacovigilence & drug safety, life sciences, clinical reserach, medical writing and data analytics.
Knowledge of global Pharmacovigilence database ARISg, processing of individual Case Safety Reports (ICSRs) originating from various sources, post-marketing non-solicited reports/Spontaneous reports, Clinical trial reports, E2B reports.
Knowledge of ICH-E2 guidelines, USFDA guidelines, EMA guidelines including GVP modules, MHRA guidelines, Health Canada pharmacovigilance guidelines, PMDA Pharmacovigilance guidelines, TGA pharmacovigilance guidelines, CFDA Pharmacovigilance guidelines related to drugs, medical devices and vaccines.
Triage and tracking all cases, Initial and final regulatory assessments, MedDRA and WHO-drug coding, case narrative. Development and maintenance of Analysis of Similar Events, Complete medical monitoring and follow-up support, processing of expedited ICSRs to regulatory authorities
Processing of ADR reports received from various regulatory sources viz. MHRA UK, Literature sources, European health authority reports
Experience in compliances, quality processes, data entry of ICSR and processing of lab data, drug adverse events, vaccines adverse events, reporting-ICSR reports and reconciliation of cases.
Good knowledge in literature search and data retrieval using various databases like ClinicalTrials.gov, PubMed, Science Direct.
Knowledge of various activities related to signal detection in Pharmacovigilance.
Good decision-making, learning and people management skills with capacity to work under pressure situations.
An efficient leader with strong analytical, problem solving and interpersonal skills