Pharmacovigilance Officer

Title: Pharmacovigilance Officer

Location:

Taguig, PH, PH

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number:

Description

• Receives, inputs, and processes vigilance reports/ adverse events reports in Vigilance System
• Point Person for submission of HPV documents to local health authority
• Submits Risk Management Plan, PSUR/PBRER, FSCA and Safety communication
• Creates Health product RMP local annexure
• Complies with local Health Product Vigilance (HPV) regulations
• Reviews Health Vigilance Agreements or any equivalent agreements
• Conducts HPV awareness training, refresher training, and re-training for alli.e. HPV team members, Healthcare employees, third party service provider under DKSH MES Healthcare)
• Conducts onboard HPV awareness training for DKSH MES new hires
• Point person for CAPA related to HPV process
• Ensures mock repor...