Global Safety Project Manager - Operations & Compliance (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:

Your tasks

Supporting the Head of Global Safety QPPV Office / EU QPPV / Graduated Plan Officer in the fulfillment of pharmacovigilance obligations, including:

• Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)
• Collection, systematic documentation and evaluation of all necessary information in connection with indications of drug risks, in particular adverse drug reactions, interactions and contraindications, as well as indications of quality defects, misuse, long-term use, abuse or counterfeit drugs
• Medical/scientific assessment of drug risks and their documentation, taking into account the statutory reporting obligations to the competent authorities
• Passing on necessary information to pharmacovigilance departments at service providers, licensees/licensors, distribution partners and affiliates within the framework of contractual pharmacovigilance agreements
• Support with periodic reconciliations with partners, subsidiaries and internal departments
• Support in the preparation of pharmacovigilance agreements
• Support in creation and maintenance of pharmacovigilance system master file (PSMF)
• Overview of the pharmacovigilance system including the establishment of suitable key performance indicators to measure quality
• Ensuring the required quality of pharmacovigilance data
• Support with GVP inspections and audits
• Creation and maintenance of standard operating procedures (SOPs) for pharmacovigilance
• Performance of pharmacovigilance trainings for employees of Dr. Falk Pharma GmbH, affiliates and license partners

Your qualification

• Successfully completed degree in pharmacy or human medicine
• Several years of professional experience in the field of pharmacovigilance
• 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 or call . We look forward to receiving your application via our online portal.