Saifuddin Bohari

Safety and Pv Specialist i @Syneos Health

Pune, IN

Literature review of abstracts & full text articles (medical journals abstracts,poster presentation, literature summary cases, conference abstracts, etc.) byidentifying all validity criteria. Literature book-in and Triage activity and creatingICSRs or multiple patients\' case- Hands-on expertise in end to end case processing in pharmacovigilance databaseincluding ARGUS and ARISg (literature, non literature, study, spontaneous). A goodworking knowledge of the AE safety profile of assigned drugs, reference SafetyInformation documents, data entry conventions and guidelines, clients\'procedures and international drug safety regulations- An awareness of global regulatory reporting obligations and organized workload toensure compliance with internal and regulatory timelines for adverse eventreporting- Communicated with clients regarding case related queries and follow up.Requested and provided follow-ups on adverse events by preparing, sending outand tracking queries- Additional Ad-hoc activities of managing work flows, taking update sessions orrefresher sessions on existing topics for which associated facing challenges.