مسئول فنی داروسازی

گروه درمان ياب

شیراز

منتشر شده 4 ماه پیش

Job Description

● Food supplements, special food for medical purposes, and drug registration applications in a timely manner. ● Supervise 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. ● Establish and maintain a system for tracking changes in documents submitted to regulatory authorities or partners. ● Support in collecting and coordinating information and preparing regulatory documentation for submission to regulatory affairs. (medicines and special food for medical purposes). ● Support maintenance of regulatory files in compliance with regulations and standards applicable to company products. ● Capable of traveling and site visits. ● Submissions to the MOH, product registration, consumer information, and all regulatory activities team working in preparing the required documentation for submitting the pharmaceutical dossier into the ministry of health including CTDs, SOPs, reports. ● Manage and conduct pharmacovigilance activities. ● Price request submission to MOH according to MOH rules for the price correction ● Maintenance of history of pricing changes. ● Fill Rolling Forecast for medicines and special food for medical purposes. ● Preparation of required document related to “ consumption correction “and submission to MOH. ● Gett quota 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 MOH shortage list on a monthly basis. ● Critically appraise clinical evidence to both payers and the MOH Insurance committee. ● Identify competitors and pricing in the therapeutic area. ● Review of all market access submission materials, including supporting Budget Impact Assessments (BIA), Pharmaco-Economic studies (PE), clinical summaries, and other materials.

Requirements

● Pharmacist (Pharm D). ● Minimum of 5 years of experience as a responsible pharmacist. ● Strong communication skills. ● Able to work under pressure and tight deadlines. ● Gender preference: Male/Female. ● Fluent in English.

Employment Type

  • Full Time

Employment type

  • Full Time

برای مشاهده‌ی شغل‌هایی که ارتباط بیشتری با حرفه‌ی شما دارد،