Head of Global Safety QPPV Office (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:

Aufgaben

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

Profil

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

Wir bieten

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 online portal.

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