Drug Safety Specialist

Job Description
The Pharmacovigilance Specialist, is responsible for activities (as delegated/assigned by their manager) which may include but is not limited to PV (Pharmacovigilance) Intake activities (including reconciliation and follow-up), Individual case safety report and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local SOPs, conducting local training, and archiving and is able to perform these tasks with minimal supervision.
The Specialist, may serve as the Back-up (BU) local Qualified Person for PV (QPPV) / BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation. In the absence of the PV Lead, they may manage day-to-day PV activities and serve as their back-up.
The items listed below are activities that can be performed by the role and is applicable for all supported countrie...