- Preparation and submission of adverse event report, safety issue report etc. including AE from Patient Assist Program to submit to specific client in time even in out of office hours and authority if required in line with AE handling SOP and PV agreement with specific client.
- Focusing on effective and timely submission of adverse event report, safety issue report etc. to specific client and follow up even in out of office hour to provide complete information to specific client required for risk management plan and CAPA.
- Submission of adverse event report, safety issue report etc. to authority and follow up with client to ensure that risk management plan and CAPA are submitted to authority in timely manner until closing of the case.
- Preparing of financial claiments for PV and safety issue related fees and expenses both internally and externally.
- Preparing and providing PV training to all HEC staffs (in annual basis and on-boarding training) as well as required by clients.
- Keeping and updating data back-up and retrievable record for all correspondence mail & process for AE reporting including reconciliation report and client PV contact point.
- To coordinate with concerned internal departments of DKSH and concerned client regarding AE reporting and safety related issue.
- To assist in all regulatory processes (Drug, Food, Cosmetic & Medical devices) regarding AE case and safety related issue.
- Sharing update regulation, guideline, procedure and report of safety issue with clients and other related internal departments.

- B.Pharm (Preferable M.B.,B.S)
- Regulatory and Pharmacovigilance knowledge
- Minimum 2 years in RA field (Preferable AE and safety reporting experience)
- English fluency and computer literate