Pharmacovigilance Officer

Location: Taguig, PH, PH Global Business Unit: HEC Job Function: Regulatory Services Requisition Number: 221551 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 reporting is conducted for system tests of VR process
• Ensures Vigilance System validation
• Point Person for HPV Audits
• Ensures that Deputy QPPV understands and performs the responsibilities stated above for HPV activities

Experience and Educational Requirement:

• A holder of any baccalaureate degree in medically-related courses
• With at least 1 year experience in PV
• With relevant training in PV conducted by Philippine FDA or reputable organization
• Must be residing in the Philippines

Requisition Number: 221551 Job Function: Regulatory Services