Zohaib Ahmed Siddiqui

Scientific Writer @Abbott

Mumbai, IN

Co-ordinating with stakeholders to collect the data for reportsLiaising with the Affiliate Safety Representatives of the different region for data collectionLiaising with license partners for exchange of data in accordance with SDEAsQuality review of the aggregate reports (PBRER, PSURs and ACO, ARs, SBRs). SME for Patient Exposure CalculationPrepared, compiled aggregate Reports (PBRER, PSURs and ACO, ARs, SBRs) in accordance with the content and format outlined in GVP moduleResponsible for management and timely submission of aggregate report to achieve 100% regulatory complianceCollating the data and preparation for QC and finalization of aggregate reportsEvaluate comments from reviewers of draft reports for appropriateness and respond accordinglyExecution of company standard operating proceduresLiaise effectively and maintain excellent relationship with the clients and internal/external contacts.Train and mentor employees in Pharmacovigilance department