(Senior) Manager Clinical Safety and Pharmacovigilance
Manages all Pharmacovigilance aspects of allocated studies and post market products;
Oversees and maintains PVA/SDEA management, as well as CRO management in respect to PV;
Ensures that all assigned projects are set-up in line with the PV standard operating procedures (SOPs) and relevant guidelines;
Serves as a contact for any pharmacovigilance matters internally and externally;
Ensures collection, submission and filing of all safety data/case processing and global safety database maintenance oversight; including serious adverse event (SAE) reports from clinical trials, spontaneous reports for marketed products and reports from the literature, as well as any social media surveillance;
Contributes to signal management;
Establishes Key Performance Indicators for the PV system and continuously monitors the global PV system compliance;
Directly reports on overall PV compliance to the Director PV, QPPV and other local persons for pharmacovigilance;
PV Audit and Inspection preparation and support;
PV training maintenance and on job training for Drug Safety Specialists;
Depending on the candidate’s skills, employee responsibilities may be added to the role.
In depth knowledge of GVP, FDA guidance documents and in general global PV legislation;
Effective communication and negotiation skills, be able to work with matrix and local teams, as well as with external partners and to be able to break down problems to find solutions;
Safety database knowledge and data visualization skills.
Medical degree or background preferred;
At least 4 years of pharmacovigilance experience;
Strong PV compliance and safety management background;
Broad knowledge of PV, especially in the field of post marketing;
Audit and Inspection experience is desirable;
Fluent in German and excellent command of English with strong written and oral skills;
In depth knowledge of international CSPV legislation.