Pharmacovigilance Supervisor

Responsabilities:
I-Establishing   and maintaining   phannacovigilance    system.
2-Completing Phannacovigilance    training for the compnay.
3-Preparing pharmacovigilance    reports according to companie's PY SOP.
4-taking in charge the requests from Health Authorities as single contact point for the Health Authorities   in 24-hour basis.
5-Providing   Health Authorities   with any other information   relevant to product safety.
6-0verview   of the safety profiles and any emerging safety concerns for the company's drugs.
7-Declaring to CNPM adverse reactions cases reported to the company within the time-limits
stipulated in Chapter VI, determined by the CNPM, and in CrOMS format. Additionally, to any new information collected as part of the follow-up of these adverse reactions, according to the same time-frames and in the same format (transferred via the professional mailbox provided by the CNPM).
8-Contact the reporter for additional   information   if any is required.
9-Transferring periodic safety update reports (PSURSIPBRERS);
l O-Submitting risk management plans to CNPM,
l l-Submitting the pharmacovigilance system master file summary (PSMF summary) to
CNPM,
I2-Submitting the European pharmacovigilance system master file (PSMF) upon request,
13-Responding to requests for documentation from the CNPM,
14-Working with the CNPM to ensure that investigations evaluating the beriefit/risk ratio of its marketed products are properly implemented.
IS-Mention the contact details of the CNPM on the local Package Leaflets/Summary of
Product Characteristics (SmPC) of health products.

Catégories: Ingénierie

Région: ALGER / ALGERIE

Publiée le: 24-03-2024 à 17:01:46