1) To initiate, prepare, and if necessary coordinate signal detection : based on case series or all the data by initiating searches on the safety data in the database.
2) To initiate, prepare, and if necessary coordinate safety reports DSERs, DSURs, ad hoc expert reports, answers to questions from the authorities and affiliates, PV investigations, or any documents regarding the analysis of the safety data.
3) To contribute to the draft of a risk management plan (PGR/RMPs) of its portfolio of products.
4) To contribute to the proofreading :
– of pharmacovigilance cases that require to be submitted to the authorities and/or partners, of its portfolio of products. The cases medical review include, inter alia, the validation and the consistency of narratives, event coding & scoring ;
– documents related to the products of its portfolio : investigator’s brochure, patient consent and information, study report, reference documents, the « saftefy » parts of the protocols for interventional and non- interventional clinical studies
5) To coordinate and conduct the monthly quality control of adverse events or reactions related to the use of prodcuts of its portfolio.
6) If necessary, participating in teams project/medical sefety team as a representative / PV actor.