مسئول فنی داروسازی

Job Description

Job Description:

• Supervise the regulatory team.
• Create and manage effective communication and close collaboration with MOH
• Keep up-to-date with the latest news in MOH, syndicates, and the pharmaceutical industry.
• Prepare and complete regulatory documentation.
• Support the commanded strategies to increase the time and accuracy of regulatory compliance.
• Support in collecting and coordinating information and preparing regulatory documentation for submission to regulatory affairs.
• Support the maintenance of regulatory files in compliance with regulations and standards applicable to company products.
• Manage and conduct pharmacovigilance activities.
• Price request submission to MOH according to MOH rules for the price correction
• Maintain the history of pricing changes.
• Fill Rolling Forecast for medicines and special food for medical purposes.
• Prepare required documents related to “consumption correction” and submission to MOH.
• Get a quote and price approval for the first shipment of the new product.
• Develop and execute strategies related to achieving organizational goals aligned with MOH to meet objectives.
• Conduct quality risk management of GDP deviations in Iran.
• Manage and conduct GDP activities including the correct distribution plans for all imported products according to the negotiation previously done with MOH distribution plans.
• Monitor and report the MOH shortage list on a monthly basis.
• Critically appraise clinical evidence to both payers and the MOH Insurance committee.

Requirements:

• Pharmacist (Pharm. D.)
• At least 5 years of experience as a responsible pharmacist.
• Familiarity with the principles of GXP (GLP, GDP, GSP, GMP, etc.) based on the international GMP guidelines approved by the General Department of Drug and Narcotics Monitoring and Evaluation (such as PIC/S, WHO, etc.)
• Strong communication skills.
• Able to work under pressure and tight deadlines.
• Fluent in English.