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LEO Pharma, Ballerup
If you have a solid understanding of guidelines across EMA/ICH/FDA, and you are looking for a job with great variety of tasks and global vision, you don’t have to look any further. At LEO you will be part of a successful and rapidly growing company, and you will join a well-functioning department known for team spirit, cooperation and genuine care for each other.
As Senior Pharmacovigilance Specialist your primary focus is to make sure that overall processes are maintained and optimised in order to submit/distribute case reports according to PV legislation and maintain a high compliance in relation to legislation worldwide. In overview your primary tasks will be to:
- Surveillance of outsourcing partner
- Maintain quality documents and processes (both for post marketing and clinical trials)
- SAE reconciliation and reconciliation of cases with affiliates and partners