Description de l'annonce:

We are looking for a Case Specialist ensure the optimized management of vigilance cases, using their scientific knowledge to enable a detailed analysis of the various files.

• Entering cases of vigilance in ad hoc databases or on formats defined with the customer
• Investigation of cases of vigilance by telephone/mail
• Pre-analysis of complex cases before entry
• Medical evaluation of records on:
• coding (according to applicable dictionary)
• the causal relationship between the effects and the taking of suspect products (according to applicable method)
• the expected/listed nature of events/effects/incidents
• the severity of the events/effects/incidents and the case
• Identifying the requirements in terms of submissions for each case
• Validation of certain documents produced by data managers / medical information assistants / documentalists: letters, phone call cards...
• Identifying the requirements in terms of the preparation of ICSR/MLM filters
• Medical information: in support of the medical information division
• Taking phone calls reporting alertness notifications
• Return of ad hoc managed calls
• Checking the lack of vigilance among lists of medical information questions and quality claims
• Preferred interlocutor of certain customers (with the support of a confirmed or the pole manager)
• Writing/putting quality provisions in place
• Related to its activities
• Related to customers for whom certain activities are carried out in the Bplants Unit
• Case Management

Experience

1-3 years of experience In a similar position

Skills

• Knowledge of current regulations
• Rigor, analysis and method
• Knowledge of computer software used, MedDRA
• Fluent in English and other languages would be a plus
• Organization and initiative