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 QPPV Office (m/f/d)
Your tasks
Team management of a group of Global Safety QPPV Office team members including leading, mentoring and developing the Global Safety QPPV Office team members, fostering a culture of compliance and excellence.
Ensuring takeover of the following global safety governance tasks and responsibilities of the Global Safety QPPV Office like:
- Management of the pharmacovigilance quality management system including deviation management and CAPA management in collaboration with the quality department
- Management and preparation of pharmacovigilance agreements based on corresponding templates incl. maintenance of templates
- Management of pharmacovigilance activities of Dr. Falk Pharma affiliates including coordination of relevant meetings, communication and reconciliation activities
- Management of global license partner activities regarding pharmacovigilance incl. coordination of corresponding meetings, communication and reconciliation activities
- Coordination and performance of Archiving and filing activities
- Support with periodic reconciliations with affiliates and internal departments
- Support with market research and patient support program activities
- Coordination, creation and maintenance of standard operating procedures (SOPs) for the pharmacovigilance department
- Performance of pharmacovigilance trainings for employees of Dr. Falk Pharma GmbH, affiliates and license partners
Supporting the Head Global Safety / EU QPPV / Graduated Plan Officer by taking over the QPPV Office function including:
- Creation and maintenance of the Pharmacovigilance System Master File (PSMF)
- Management of inquiries to the QPPV
- Creation and coordination of safety metrics and overviews of the pharmacovigilance system including suitable key performance indicators to measure quality
- Coordination of GVP inspections and audits
Your qualification
- Successfully completed degree in natural sciences, pharmacy or human medicine
- Several years of professional experience in the field of pharmacovigilance, especially QPPV Office functions
- Several years of management experience
- Strong team player and excellent communication skills Very careful and accurate way of working
- High degree of reliability
- Very good written and spoken German and English skills
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