Job Description
The role oversees the daily operations of product registration, pharmacovigilance, and controlled drug management for the Healthcare Business Unit of DKSH Singapore. It includes ensuring that all operational procedures comply with the requirements set by local regulatory authorities. In addition, the position serves as the registered pharmacist for licences under the Health Products (Therapeutic Products) Regulations and the Medicines Act.
This position reports to Senior Manager, Medical Affairs.
Key Responsibilities:
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 report (ICSRs) for accuracy and completeness.
Follow up with report...
This position reports to Senior Manager, Medical Affairs.
Key Responsibilities:
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 report (ICSRs) for accuracy and completeness.
Follow up with report...
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