Head of Global Safety QPPV Office (mfd)

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

• 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

• 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