International Open Positions
With 530 years of heritage, more than 3.000 employees, a leading Research and Development Center and two major production sites in Prague and Bucharest, Zentiva strives to be the champion of Generics to support the daily healthcare needs of people living in Europe.The growth of our organization brings new opportunities for our people to fulfil their potential. It also positions us well to attract the best talent and retain our team to secure our success for future generations. Join us!
PV Case Management Specialist
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 either French, German and English case reports and need to communicate follow-up requests in these languages.
- Reporting mailbox check
- Case reports intake, personal data redaction, translation DEEN or FREN,
- Duplicity check and data entry
- Peer to peer Quality check
- Follow-up in English and German or French
- 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
- Experience in case management (either clinical or post-marketing) in the sense of * GVP module VI
- Fluent English and one additionally French or German language is a must
- 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
- PV Safety database ARISg
- Challenging career opportunity to work for a successful international company
- Opportunity to broaden your knowledge and expertise in your field
- Possibilities for own personal growth and further language development
- Competitive remuneration and wide portfolio of employee benefits
- Above-standard social, healthcare and educational program