سارة على ابراهيم على مرجان

pharmacovigilance manager في pharmaceutical company

• مصر - الإسكندرية
• أشغل هذه الوظيفة منذ يونيو 2013

acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities
•trained and knowledgeable about pharmacovigilance, quality and medicinal products covered by the pharmacovigilance system.
•responsible for the establishment and maintenance of the pharmacovigilance system.
•Acts as a contact point for the ICSR reporting.
•Is in charge of developing and maintaining the company Pharmacovigilance System Master File (PSMF)
•Ensures the information in the PSMF is accurate and up-to-date.
•Can access all information relevant to the maintenance of the pharmacovigilance system, product safety and promotion of compliance to the legal requirements with reference to The Common Arab Guidelines For Pharmacovigilance version 2, Dec.2014.
•Has an overview of the safety profile and any emerging safety concerns in relation to the medicinal products.
•Ensures the timely submission and quality of Individual Case Safety Reports (ICSRs)
•To conduct general and specific training programs of Pharmacovigilance to :
oMarketing & Scientific offices
oTechnical directorates involved in a PV activity
oPharmacovigilance team
oAuditors
oOther company employees not involved in a PV activity
That's to increase Pharmacovigilance awareness within Amriya Company for Pharmaceutical Industries.
•developing and maintaining our company products' PSURs, RMPs.