Job Description
Responsibilities
- 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.
- 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.
- Receive and review individual case safety reports (ICSRs) for accuracy and completeness.
- Follow up with reporte...