◦ 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