Quality Assurance & Pharmacovigilance Responsible Person

Be a part of the winning culture!
At Zentiva, we are a team of 4,800 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.

Quality Assurance & Pharmacovigilance Responsible Person

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

The main focus would be on tmaintaining 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.

What Would Be Your Main Responsibilities

• 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 to 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 implementing 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• Deciding on the postponement or destruction of returned, rejected, withdrawn, or counterfeit medicines or decision on returning a medicine or medical device into saleable stock.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 following 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.

We Need You To Have

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

It is crucial for us to have satisfied employees. Therefore, we can offer you the following:

• Competitive salary;
• Additional benefit package;
• International working environment and a passionate team of professionals;
• Continuous Learning & Development opportunities thanks to our Zentiva Academy;
• A hybrid form of work - on-site & off-site.
   

Diversity is a fact. Inclusion is an act @Zentiva
At Zentiva, we are a team of almost 4,800 unique talents bonded together by our mission to deliver high-quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva.