We are continuously looking for experienced pharmacovigilance professionals to reinforce our Valesta team.
- You are fluent in English?
- You have experience with safety and regulatory data?
- You see report writing as a daily part of your job?
Then you might be the Pharmacovigilance professional we are looking for!
- Reviewing, assessing and processing safety data for phase I, II & III clinical trials and marketed products
- Maintaining information about all SAEs/ADRs in a secure location, in accordance with local regulations
- Tracking of regulatory guidelines and directives related to Medical Affairs department activities
- Maintaining a ‘list of Authorities and other official bodies’ to whom SAEs/ADRs should be reported, as well as corresponding reporting procedures
- Review of listings, concomitant therapy, line listings, clinical trial protocols, …
- Report writing: narratives, DSURs, PSURs, product related expert reports, ISSs, Clinical Expert Statements/Clinical overviews for registration reneweal purpose, involvement in writing of the safety section of the IB, SDEA, SPP,…
- Direct reports, backup and internal/external communication
- You are a Medical doctor, Pharmacist, PhD or equivalent by experience
- Experience within pharmacovigilance is preferred
- You are fluent in English, knowledge of French or Dutch is an asset
- You have excellent organisational skills
- You show strong planning skills and easily respect timelines
- You are a flexible team player, highly rating confidentiality
- You are very punctual and accurate in your work
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