Head of Global Safety QPPV Office (m/f/d) in Freiburg

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:

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

If you have any questions, please do not hesitate to contact Sabine Aicher at personal@drfalkpharma.de or call 0761 1514-253. We look forward to receiving your application via our .