Regulatory Affairs Officer and Deputy Drug Safety Representative | Beirut

On demand
Posted on June 9, 2021 - 3 days ago - Beirut
On demand
Healthcare, Medicine & Pharmaceutical

Regulatory Affairs Officer and Deputy Drug Safety Representative | Beirut

The regulatory affairs officer and deputy drug safety representative is responsible for preparation of invoices and declaration forms, Settling of importation taxes with assigned legal bodies and acting as a Deputy Safety Representative.

Importation Duties:
• Preparation and Submission of requests to the Ministry of Public Health-Import/Export department.

• Collection and prepartion of permits from the Ministry of Public Health
• Settling Importation taxes to the Order of Lebanese pharmacists and physicians
• Filling and updating corresponding trackers.

• Preparation of clearing files to be collected by clearing agents.

• Collection of Refunds related to Free Medical Samples, Duplicate invoices, cancelled shipments from the Lebanese Order of Pharmacists.

Deputy drug safety representative duties:

• Handling of ICSRs, and ensure prompt reporting within the agreed timeframe.

• Handling of MIEs and PTCs associated with AEs.

• Perform monthly reconciliation with suppliers and internally with involved departments.

• Screening of local literature journals.

• Handling of deviations and CAPA related to reporting and PV system.

• Tracking and Archiving of PV related documents
• Back-up for the drug safety representative in regard revision of SDEA’s and SOPs with business partners.

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