Job Description

Are you detail-oriented, analytical, and interested in pharmaceuticals and patient safety? Join our Pharmacovigilance team and help ensure that adverse event reports are accurately processed and handled in line with regulatory requirements.

The successful candidate will be responsible for the end-to-end case processing, from case intake and follow-up requests through data entry and quality checks to reporting cases to regulatory authorities or business partners.

Your Responsibilities:

• Working with adverse event reports received from patients. Study, understand, and correctly apply relevant legislative and regulatory requirements when processing individual cases.
• Responsible for case processing from case intake, follow-up request, data entry and check to reporting to authorities or business partners.
• Reporting mailbox check
• Case reports intake, personal data redaction, translation GEàEN, duplicity check and data entry, peer to peer quality check
• MedDRA coding, listedness and causality evaluation
• EudraVigilance triage and import
• Reporting to authorities and partners
• Monthly and quarterly reconciliations
• Documentation of the activities

We Require:

• University / Bachelor’s degree, preferably in chemistry, natural sciences, or pharmacy
• Fluent English (advanced level); Czech is required (minimum B1 level is required)
• Strong attention to detail and accuracy, ability to work with minimal supervision
• Proficiency in Excel, Word, PowerPoint, and SharePoint
• Technically proficiency
• Ability to navigate professional and scientific texts, find relevant information, and apply it in practice
• An interest in pharmacovigilance (PV), medicinal products, and healthcare
• Previous experience in Case Management or PV is an advantage
• Motivation to learn and adopt new processes
• The ability to work with deadlines, prioritize tasks, and regularly report on results
• The candidate should be meticulous, systematic, detail-oriented, and able to analyze available information
• The workload can be demanding during certain periods, so resilience to stress and the ability to maintain work quality under pressure
• Strong teamwork, open communication, and the ability to collaborate effectively with colleagues across the team and with other stakeholders
• Very good time management

Diversity is a fact. Inclusion is an act @Zentiva

At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. 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.