Responsibilities
- 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