Shravan Kumar
Angestellt, Pharmacovigilance Manager, Koanaa Healthcare Limited/ Shilpa Medicare Limited
Über mich
Dear Recruiter, I am a Pharmacovigilance professional with12 years with strong technical skills to handle diverse global pharmacovigilance activities in Clinical Trials and Post Marketing phases of product lifecycle which includes Handling of ICSRs, PADERs, PSURs/PBRERs, safety review reports, global RMPs, PSMF and SDEAs, queries from agencies. Extensive experience in writing PV SOPs. Interactions with cross-functional teams across continents and coordinating with QPPV/affiliates/third parties for smooth workflow. As SME in two FDA inspections. I have completed A2 level of German language and planning to pursue B1 level. I am ready to bear the Visa and travelling expenses if I get the Job opportunity. I am willing to relocate to any city in Germany. Please feel free to contact me for additional career details and qualifications. I look forward to hearing from you at your earliest convenience. Thank you for your time and consideration of my candidacy. Sincerely, Shravan Akena
Werdegang
Berufserfahrung von Shravan Kumar
Bis heute 4 Jahre und 1 Monat, seit Mai 2020
Pharmacovigilance Manager
Koanaa Healthcare Limited/ Shilpa Medicare Limited
Pharmacovigilance, PSURs, PBRERs, PADERs, RMP, Safety Review Reports, PSMF, SDEAs and ICSRs, Monthly compliance reports, Audits and Inspections and Training, SOPs, Regulatory Intelligence, GVP Modules, 21 CFR 11 Post Marketing Regulations and REMS
2 Jahre und 2 Monate, Apr. 2018 - Mai 2020
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