Responsible for review of investigational current drug safety reports (INDSR) and submission to FDA (as applicable)
Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
Supports PV Clinical Specialists in tasks and projects as needed
Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
Acts as single point of contact with key stakeholders for safety related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management