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

Fähigkeiten und Kenntnisse

Pharmacovigilance
PBRERs
Risk Management Plan
Good Pharmacovigilance Practice
Pharmacovigilance System Master File
Safety Data Exchange Agreements
PSMF
SDEAs
Patient Safety
Signal Management
PSURs
ICSRs
Compliance
German as a foreign language
English Language
independent
Team work
Leadership skills
Responsible

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

    Assistant Manager Pharmacovigilance

    Micro Labs Ltd

    Pharmacovigilance, PSURs, PBRERs, PADERs, RMP, Safety Review Reports, PSMF, SDEAs and ICSRs

  • 1 Jahr und 5 Monate, Dez. 2016 - Apr. 2018

    Team Leader Pharmacovigilance

    Cognizant Technology Solutions, India

    Pharmacovigilance, PSURs, PBRERs, PADERs and ICSRs

  • 1 Jahr und 7 Monate, Juni 2015 - Dez. 2016

    Senior Drug Safety Associate

    Hetero Drugs Limited

    Pharmacovigilance, ICSRS, PSURS, PBRERs, PADERs

  • 3 Jahre und 3 Monate, März 2012 - Mai 2015

    Senior Drug Safety Associate

    TechMahindra

21 Mio. XING Mitglieder, von A bis Z