PV Case Management Specialist
- Adresa U kabelovny 130/22, 102 00 Praha-Dolní Měcholupy, Czech Republic
- Pracovní úvazek Full-time work
Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4,500 people and a network of production sites - including flagship sites in Prague and Bucharest - Zentiva strives to be the champion of branded generic medicines and OTC products in Europe to better support people’s daily healthcare needs.
At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high-quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators, and governments to provide the everyday solutions that we all depend on.
The successful candidate will be responsible for case processing from case intake, follow-up request, data entry and check to reporting to authorities or business partners. The candidate will work with English and German/ French case reports and need to communicate follow-up requests in these languages.
- Reporting mailbox check
- Case reports intake, personal data redaction, translation DE & EN
- Duplicity check and data entry
- Peer to peer Quality check
- Follow-up in English and German
- MedDRA coding, listedness and causality evaluation
- EudraVigilance triage and import
- Reporting to authorities and partners
- Monthly and quarterly reconciliations
- Documentation of the activities
- Any other case management associated matters as defined in GVP Module VI.
University / Bachelor degree preferably in chemistry/natural science/pharmacy
Fluent English (advanced) and German language (intermediate)
Sense for details and accuracy, ability to work with minimum supervision and escalate relevant information to management
Computer skills – proficiency with excel, word, power point, sharepoints
Experience in the fields below are advantage:
Other areas of Pharmacovigilance, Regulatory Affairs in Pharmaceutical Industry
Experience in case management (either clinical or post-marketing) in the sense of GVP module VI
PV Safety database ARISg
- An opportunity to work for in an international environment
- An opportunity to broaden your knowledge and expertise in the field of drug safety
- Work in friendly environment
- Continuous personal development
- An attractive compensation & benefits package
Zentiva je moderní zaměstnavatel, proto nabízíme široký výběr benefitů, který osloví opravdu každého.
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