Responsible for daily operation of product registration related activities, pharmacovigilance and controlled drug management for the Healthcare Business Unit of DKSH Singapore.
Ensure all operational procedures are in compliance with the requirements of the local Regulatory Authorities.
Registered pharmacist for the licences under the Health Products (Therapeutic Products) Regulation and Medicines Act.
Regulatory Affairs
Pre-market activities: product assessment and new product registration.
Post market activities: variation application, product licence renewal and maintenance.
Permit application: named‑patient permit, advertising permit & sale promotion permit and any permit to allow importation or exportation.
Pharmacovigilance (PV)
Receive and review individual case safety reports (ICSRs) for accuracy and completeness.
Follow up with reporte...
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