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
General 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 reporter for clarification and completion when necessary
Report ICSR and safety information to clients and health authority within stipulated timelines
Train relevant persons regarding safety information, pharmacovigilance, medical device vigilance and other healthcare products
Manage pharmacovigilance, medical device vigilance and other healthcare products database
Manage relevant aspects of safety agreement with clients
Manage and ensure compliant safety reporting in according with standard procedures, safety agreement and local regulations.
Coordinate with clients and relevant functions for FSCA reporting to health authority within stipulated timelines
Responsible for clients and health authority audits
Responsible for PV reconciliation with clients
Registered Pharmacist
Managing controlled drug distribution: inbound, outbound, daily stocks reconciliation, maintenance of manual records, reporting to HSA, destruction and security audit
Ensure compliance to the licensing requirements in the importation, wholesale and distribution of health products:
focusing on the management of authorised activities and the accuracy and quality of records
ensuring that suppliers and customers are legally approved or authorised to enable lawful supply of health products
Ensure SOPs and documentations are properly maintained.
Manage and work closely with different internal stakeholders and clients to establish a collaborative effort to achieve fulfillment of deliverables.
Job Requirements:
Possess a Degree in Pharmacy
Registered Pharmacist with Singapore Pharmacy Council
Comes with more than 2 years of experience in pharmaceutical industry setting
