Qualified Person for Pharmacovigilance (QPPV) (m/f)

Beschreibung

• Acting as EU Qualified Person for Pharmacovigilance (QPPV)
• Ensure tasks of all drug safety aspects (e.g. evaluation and documentation of adverse events, coordination and providing of worldwide periodic safety reportings and risk management plans, SOPs and further drug safety related documents)
• Create high quality documents for inspection readiness (e.g. PSMF)
• Organization and maintenance of the internal drug safety system in cooperation with Quality Assurance, Clinical Development and the general management
• Ensure appropriate communication with global health authorities
• Provide safety advice to other departments (e.g. Clinical Development)

• University degree in Pharmacy or Medicine with a PhD and/or MD
• Profound experience within the industry, preferably including both Clinical Development and Pharmacovigilance experience (including medical safety evaluation and safety based decision making)
• Qualification as EU Qualified Person for Pharmacovigilance (QPPV)
• Highly motivated and independent scientist with excellent knowledge of ICH, GCP and AMG
• Very good knowledge and strong hands-on experience in the field of drug safety (e.g. safety reporting, internal drug safety system)
• Excellent verbal and written communication skills in English and German
• High level of business awareness, initiative and ability to work independently
• Excellent planning and organizational skills