Head of Drug Safety (m/f)

REFERENZNUMMER:

353255/11

IHRE AUFGABEN:

-Develop and maintain the Global Drug Safety system according to organizational processes, external requirements and internal needs
-Ensure that global pharmacovigilance and risk management is meeting internal and external regulatory requirements and quality standards
-Chair the Drug Safety Committee
-Establish and maintain the pharmacovigilance system
-Prepare reports for competent authorities of the EU member states (as applicable)
-Provide input where applicable to clinical study protocol writing (safety section) and labelling activities
-Ensure continuous overall pharmacovigilance evaluation during the post-authorisation period
-Maintain overview of the safety profiles and any emerging safety concerns for all approved customers medicinal products and maintain overview on safety profiles and any safety concerns regarding all customers investigational compounds
-Act as the focal drug safety contact point to the outsourced EU QPPV
-Act as a local QPPV for Switzerland

IHRE QUALIFIKATIONEN:

-In-depth experience in Drug Safety in the pharmaceutical industry
-Strong leadership skills
-Fluency in written and spoken English, knowledge of German is also of advantage
-Excellent computer skills
-Good communication skills
-Self motivated team player

WEITERE QUALIFIKATIONEN:

Drug safety manager