- Postes vacants:
- 1 poste ouvert
- Type d'emploi désiré :
- Temps plein
- Experience :
- 3 à 5 ans
- Niveau d'étude :
- Doctorat, PHD
- Rémunération proposée :
- Confidentiel
- Langue :
- Français, Anglais
- Genre :
- Indifférent
Description de l'emploi
The PV Senior Officier is in charge of following or assisting on projects with Pharma, Medical Devices or Cosmetics Companies. Projects may include the following tasks, based on the candidate specific experience (see SKILLS)
Job Function: Senior Pharmacovigilance Officer
Type: Full-time employee temporary contract
Duration: 12 Months (minimum but reconductible)
Seniority Level: Senior (4+ years in pharma industry or consulting for pharma)
- Preparation or review of Policies, SOPs and WIs for pharmacovigilance
- Preparation and on-site execution of GVP audits as lead auditor
- Preparation or review of GVP audit reports and subsequent CAPA review
- Preparation or review of DPIAs and documentation connected to the EU GDPR applied to the pharmacovigilance and clinical research areas
- Preparation or review of CSV documentation for systems in use in pharmacovigilance
- Execution or support to execution of OQ and PQ tests
- CSV documentation on-paper audits
- Preparation and on-site execution of PV software vendors audits
Exigences de l'emploi
Skills Required:
- GVP Audits
- PV Quality Assurance and Quality Systems oversight
Either in:
- Computer Systems Validation
Having experience in all these areas will be a relevant added value.
Additional Required skills:
- GVP Knowledge
- Good written and spoken English
- MS Outlook, Word, Excel
- Good communication and personal organisation
- Flexibility
Optional skills:
- GAMP Knowledge
- EU GDPR Knowledge
- PV Databases knowledge (ARISg, Argus Safety…)
- GANTT Knowledge
If interested, please send us a cover letter and CV with the reference: « SPVO_Tunis » in the subject of the email.
Date d'expiration
13/03/2020