The Regional Pharmacovigilance Officer (RPVO) is responsible for specified activities that support the Pharmacovigilance (PV) Country Lead and PV Regional Lead.
This includes the procedural responsibilities in :
Country level audits and inspections, aggregate safety report distribution, health authority submission compliance (individual case safety reports and aggregate safety reports), local and regional contractual pharmacovigilance agreements, training tracking, and case work (if needed) with countries.
As requested by the GS Regional Leads, the RPVO may undertake other additional activities including projects and back-up activities for a PV Country Lead.
The RPVO routinely interacts with the PV Regional Leads, PV Country Operations staff and Global Safety Headquarters staff, as well as colleagues from Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units.
Some travel may be required.
The position reports to the Pharmacovigilance Regional Director in Latin America