Dr. Günter Gartenmaier

As Global Head Case Processing, I am managing receipt, processing and reporting of all case types as per internal and external/legal requirements. Supported by my team I need to control affiliates and central case processing sites with regard to key performance indicators and compliance. The whole system requires continous improvement and adoption to new regulatory requirements and must be always ready to be presented in authority inspections in full compliance. Furthermore, I am acting as deputy EU QPPV.

As Head of Data Analysts, I was responsible for the team retrieving data from the global safety data base for any kind of aggregate reports, for maintenance of the Argus Saftey data base including management of all European reporting requirements. During that time I was leading the project teams for XEVMPD/article 57 (2). Furthermore, I was acting as deputy EU QPPV and deputy Stufenplanbeauftragter.

As Manager Drug Safety and Pharmacovigilance, I was responsible for case review and submission on European headquarter level. Furthermore, I was the designated safety expert of the team responsible for a specific application procedure at the European Health Authority (EMA).

As Drug Safety Officer, I was responsible for case review and submission on local, German affiliate level. Furthermore, I was in charge of answering medical queries and retrieving follow up information from physicians.

As Medical Expert for psychotopic drugs, I was responsible for case review and submission on local, German affiliate level. Furthermore, I was in charge of answering medical queries and retrieving follow up information from physicians.

As resident physician I was taking care of patients with schizophrenia, depression or compulsive diseases.

As Scientific Advisor, I was responsible for the assessment of medical expert statements on drug safety and risk-benefit ratio provided to BfArM as part of dossiers.