Pharmacovigilance & Regulatory Affairs Executive

Pharmacovigillance

• Conduct the PV training/ refresher training for new employees/ exist employees.

• Report individual AE case to PV Regional and periodically report to ADR agency as per required timeline.

• Regularly cross check the employee list (monthly) to update PV training for new employee in timely manner.

• Coordinate with cross functions (MKT/ Medical, QA/RA…) to handle customer complaints, inquiries which are related to using products.

• Conduct PV training for stakeholders of Eisai (vendors/ hospitals…) if required.

• Follow up and update the list of vendor, PV Agreement frequency (at least twice a year).

Participate in Recall process of Eisai.

• Reconcile customer complaints/ AE cases with PV department of local distributor.

• Share the update PV information from Authority and/or Regional PV to all Department Managers in timely manner.

• Retention hard copy of PV reports forever, PV Agreement within 7 years and liquidation report in accordance with SOP of document control. Scanned documents are kept in PV share folder of Eisai forever.

Regulatory Affair

• Prepare variation dossiers, GMP declaration of manufacturing sites

• Submit and follow up the feedback of Authority and prepare the supplement dossier as per request.

• Prepare/ review the artwork before and after approval. Notify to other relevant functions.

• Participate in internal inspection annually or well preparation for Corporate audits.

• Other tasks if required. (RA).

• Bachelor’s degree Pharmacy

• Good in communicate and strong management skill

• Able to function within a quickly changing working environment with a high stress level and continuous time pressure.

• Experience in SAP software is preferable.

• Demonstrate proficiencies in MS Office (e.g. Excel, Word and PowerPoint)

• Good in English, both written and spoken.