Pharmacovigilance Officer

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 Requirem...