Rooman Haidery
Manager - Pharmacovigilance @Ipca Laboratories Limited
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WORK HISTORY
Manager - Pharmacovigilance @Ipca Laboratories Limited
Mumbai, IN
Team ManagerVendor ManagementVendor Audit SDEA ManagementICSR ManagementICSR Management :End to End ICSR ProcessingArgus DatabaseDrug safety mailbox MonitoringPV activity of Clinical Trials & BA-BE studiesCdsco SUGAM Portal ManagementLiterature search via EmbaseRegulatory Submission-USFDA-EMA-TGA-MHRA-All ROW Countries -PVPI/DCGI-Russia HAEudravigilance activity - L2A Downloads - MLM Search MHRA Downloads Local Literature MonitoringSOP preparation/reviewCCDs preparation & reviewTeam TrainingNew Joiners InductionCoordinate with QPPV
EDUCATION
Bandra College, Mumbai
HSC
HKES College of Pharmacy
M.Pharm, Pharmacology
Luqman College of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Kendriya Vidyalaya
SSC
SKILLS
ABOUT ROOMAN HAIDERY
Work Experience Ipca Laboratories Ltd, Jun 2017 - Till Date, Manager-PharmacovigilanceTCS, May 2012-Apr 2015 as Pharmacovigilance Scientist. Cognizant Technology Solutions, Apr 2015 - Jun 2017 as Pharmacovigilance Data Analyst. Education Master’s degree (M. Pharm), specializing in Pharmacology at Rajiv Gandhi University of Health Sciences, Bangalore, India. Bachelor’s degree in Pharmacy at Rajiv Gandhi University of Health Sciences, Bangalore, India. Interested in Pharmacovigilance, Medical Affairs and Drug Safety.Currently working at Ipca Laboratories Ltd as Manager - Pharmacovigilance, since June 2017. Current activities performing:Team Handling Activities Management:Vendor ManagementVendor AuditEnd to End ICSR activity Drug safety mailbox monitoring Submission of clinical trial SAE file to DCGI (Cdsco SUGAM Portal Management). AE/SAE Management from Clinical Trails/BA-BE Studies- Literature search via EmbaseRegulatory Submission-USFDA-EMA-TGA-All ROW Countries -PVPI/DCGI-Russia HAEudravigilance activity - L2A Downloads - MLM Search - MHRALocal Literature MonitoringSOP preparation CCDs preparation & reviewPBRER (need basis)Team TrainingNew Joiners Induction training
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