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Pharmacovigilance

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  • Pharmacovigilance
◦ local responsible person for Pharmacovigilance (LPPV) – local responsible person for Pharmacovigilance (LPPV)
◦ collection and management of safety data in defined territory
◦ Consultancy on applicable laws and legislation changes relating to Pharmacovigilance
◦ Reporting to EU Qualified Person for Pharmacovigilance (QPPV) nominated by MAH
◦ Maintainance of pharmacovigilance systems (such as standard operating procedures, work instructions, training) and resources
◦ PV training of local affiliates (sales teams etc.)
◦ Weekly local medical and scientific literature screening not covered by in  ternational databases
◦ Medical information inquiries handling
◦ Internal QC systems for PV and compliance monitoring for employees
◦ Representing MAH in case of local HA audits



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