Details:

Ihre Aufgaben:

• Working as § 63a AMG Stufenplanbeauftragter
• Primary liaison with the EUQPPV (ability to act as deputy) and 3rd party provider of PV services, 3rd party medical services provider and global PV
• Management of the PV team in Germany and matrix leadership of PV activities across Europe.
• Oversight of receipt, collection, processing and documentation of all incoming pharmaceutical and medical inquiries, adverse events and PV related complaints
• Communication with responsible competent authorities regarding potential drug safety risks
• Timely compilation and submission of aggregated reports and other PV-related documents
• Ownership of PV Quality Management Systems
• Primary contact for PV inspections in Europe. Member of the European Drug Safety Committee
• Liaising effectively across the organization

Ihr Profil:

• Degree in Pharmacy or comparable scientific education (Biology, Chemistry, Medicine etc.)
• Minimum 3 years direct experience in Good Pharmacovigilance Practice
• Profound medical and pharmaceutical knowledge
• Excellent understanding of PV requirements for generic medicines
• Analytical way of thinking combined with flexibility and structured working attitude
• Leadership experience, working as a line manager and/or extensive matrix management experience
• Project management experience
• Track record of successfully implementing system changes
• Experience of successfully operating in a multicultural, international, organization
• Business fluency in German and English