Zentiva is a Pan-European Platform developing, manufacturing and providing high quality and affordable medicines to more than 100 million people in Europe. We offer solutions in key therapeutical areas such as Cardiology, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. We are e team of almost 5000 unique talents bonded together by our purpose to provide health and wellbeing for all generations.

Currently, we are looking for Quality Assurance & Pharmacovigilance Responsible Person to join our highly motivated team and inspired team in Zentiva, N. Macedonia

The main focus would be on implementation and maintenance of a Quality system in accordance with the guidelines of Good distribution practice and the corporate QMS (Quality Management system) and management of the company’s Pharmacovigilance system and ensuring local compliance with applicable Pharmacovigilance regulations.

Responsibilities of the role:

• Keeping records and maintaining the quality system in accordance with the Guidelines of Good Distribution Practice in the distribution of medicines and medical devices and reviewing quality documentation related with all quality standard implemented in company.
• Reporting of doubt in the quality of the medicine or medical device, or deviation from the quality standard
• Monitoring of adverse reactions of medicines and medical devices
• Managing the customer complaint procedure
• Managing the customer and supplier approval process
• Development of plans and timelines for internal control and participation in the implementation of internal and external inspections
• Deciding on the postponement or destruction of returned, rejected, withdrawn or counterfeit medicines or decision on returning a medicine or medical device into saleable stock.
• Development and implementation of training plans for initial and continuous training
• Acting as a single contact point for the Health Authorities on a 24-hour basis B5
• Submitting ICSR and PSURs in accordance with local requirements related to Pharmacovigilance.
• Having an overview of the safety profiles and any emerging safety concerns for the company's drugs
• Receive, report and follow-up as necessary, spontaneous adverse event reports. 
• Provide training to relevant staff related to their pharmacovigilance responsibilities

Main requirements:

• Relevant university degree (Faculty of pharmacy, Faculty of medicine)
• Min. 2 years of Regulatory affairs preferably as a QA and PV
• Very good level of English (both written and spoken)
• Very goon knowledge in MS Office
• Attention to details, Self management, Team player
• Very well organized with ability to prioritize effectively

Please send your CV to the following e-mail address: [најави се за да го видиш е-маилот]