Medical Monitor/Clinical Research Scientist/Safety Physician/Pharmacovigilance

10/2016 – 1/2020

• Leading the Global Medical Monitoring team, assuring medical oversight of all ongoing vaccine studies including Investigator Initiated Sponsor research and Phase IV studies
• Reviewing/authoring (as applicable) clinical documents, including study designs and protocols (co-responsibility for quality of all related clinical study documents), development plans, publications and integrated clinical documents for regulatory submissions, as well as internal and external presentations
• Supporting the development of a strategy for all study types within VBU i.e. post-marketing commitments, IIRs and Health Economics and Outcome Research
• Building a Key Opinion Leaders network for vaccines in partnership with Medical Affairs
• Serving as clinical contact point for ongoing alliance projects and supporting collaborative planning and mapping of evidence generation activities

Medizinforschung

2/2011 – 9/2016

• Leading the Global Development team in Germany (CTMs, CRAs and CTAs)
• Medical oversight of all clinical studies executed in German speaking countries and Scandinavia, Flu program in US
• Supporting the development and execution of medical and scientific strategies relating to clinical development, introduction and use of vaccines
• Supervising international clinical studies, including planning and control of study budget and timelines, service provider selection, contracting
• Supervising the development of study specific documents (protocol, CRF, clinical study report, etc.) and generation of program specific clinical documents (CDP etc.) and publications
• Ongoing review of clinical study data, final analysis and interpretation
• Medical education and training of the regional study team and site study team
• Study and disease related interactions with KOLs and HCPs

Medizinforschung

9/2006 – 1/2011

• Deputy QPPV
• Responsible for Risk Management Plans
• Coordinating, planning and conducting PV audits, issuing audit reports and approving corrective actions
• Analysis of monthly compliance data regarding ICSRs and PSURs
• Preparation, review and update of Pharmacovigilance SOPs/GOPs/WIs
• Preparing and responding to health authority inspections
• Preparation of Periodic Safety Update Reports (PSURs)
• Review and medical assessment of Individual Case Safety Reports (ICSRs) reported spontaneously, from trials or retrieved from the scientific literature

Pharmaforschung