Pratik
Pharmacovigilance Associate at Symogen Limited
New Delhi, NCT, India
"I Rock! Myself Pratik Vikash Singh"
ABOUT ME
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 ...
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, ...
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Symogen Limited - Pharmacovigilance Associate
Apr 2014 - Present (7 years and 6 months)
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Symogen Limited - Pharmacovigilance Associate
Apr 2014 - Present (7 years and 6 months)
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Symogen Limited
Symogen Limited
Symogen Limited
Apr 2014 - On Going
Work Type: Full-Time
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JOB TITLES, RESPONSIBILITIES & CONTRIBUTIONS
Pharmacovigilance Associate
Apr 2014 - On Going
Symogen Limited
Symogen Limited
Symogen Limited
Apr 2014 - On Going
Work Type: Full-Time
Industry:
JOB TITLES, RESPONSIBILITIES & CONTRIBUTIONS
Pharmacovigilance Associate
Apr 2014 - On Going
  • • Assessment of case reports for seriousness, causality and expedited reportability. • Adverse event case entry, coding and narrative writing of ICSRs
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