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

Education

Bachelors in any Science Related field

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

Organisation and initiative