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:

Wenn Sie eine Bewerbung abschicken möchten, klicken Sie bitte auf die Schaltfläche "Bewerben", nachdem Sie die gesamte Beschreibung gelesen haben.

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 xjliken 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.