Pharmacovigilance Supervisor
- مكان العمل الجزائر العاصمة, الجزائر
- تاريخ نهاية الصلاحية 23 ماي
- مستوى المشاركة مؤكد / من ذوي الخبرة
- قطاع النشاط الصناعات
- Niveau d'étude (diplome) الدكتوراة
- عدد المناصب 01
- نوع العقد عقد غير محدد المدة
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.