Head of Global Safety Product Leads PV Operations & Trial Management (m/f/d)

As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for: Head of Global Safety Product Leads PV Operations & Trial Management (m/f/d) Your tasks
Team management of a group of Global Safety Product Leads acting also as Business Process Owners for PV Operations & Trial Management including leading, mentoring, and developing a team of Global Safety Product Leads, fostering a culture of compliance and excellence.
Ensuring takeover of the following tasks and responsibilities of the Global Safety Product Leads group:

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures
• Preparation of periodic safety reports
• Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents
• Maintenance and shaping of the processes regarding PV Operations (especially case processing and associated topics) and Trial Management (especially clinical safety related documents and reporting)
  

Supporting the Head of Global Safety / EU/UK QPPV / Graduated Plan Officer in the fulfillment of pharmacovigilance obligations
Responsibility as Deputy Graduated Plan Officer according to

• 63a AMG in absence of the Graduated Plan Officer
  

Responsibility as Deputy EU/UK QPPV in absence of the EU/UK QPPV
Responsibility As Global Safety Physician

• Available to QPPV to discuss medical issues in form of a 24/7 on call system as required
• Review of safety relevant data in clinical trials or for marketed medicinal products
• Review of adverse events as required and assessment of their severity, causality and expectedness
• Participation in drug safety review committees (i.e. patient safety committee) and provision of medical expertise. This task includes the definition and triggering of suitable risk minimization measures in case new safety signals are detected.
  

Your benefits

• Supportive, respectful and appreciative work atmosphere in a small, dedicated team
• Diverse learning culture and individual development opportunities
• International and growing family business with short decision-making processes, financial independence and long-term perspective
• New work, flexible working hours and mobile working
• Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
• Comprehensive onboarding and mentoring program
  

In addition to adequate remuneration, we offer a secure and interesting job in a competent and open-minded team. If you have any questions, please do not hesitate to call Sabine Aicher at . Your contact: Personnel department Dr. Falk Pharma GmbH Leinenweberstraße 5 79108 Freiburg im Breisgau #J-18808-Ljbffr