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. Team management of a group of Global Safety Product Leads including leading, mentoring, and developing a team of Global Safety Product Leads, fostering a culture of compliance and excellence.
Ensuring takeover of the following tasks and responsibilities of the Global Safety Product Leads group:
Global pharmacovigilance product responsibility for the medicinal products
Monitoring of the benefit-risk profile
Signal management: signal detection, signal validation, signal evaluation
Risk management: preparation of risk management plans, supervision of risk minimization measures
Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents
Supporting the Head of Global Safety / EU/UK QPPV / Graduated Plan Officer in the fulfillment of pharmacovigilance obligations, including
Medical/scientific assessment of drug risks and their documentation, taking into account the statutory reporting obligations to the competent authorities
Ensuring the required quality of pharmacovigilance data
Responsibility as Deputy Graduated Plan Officer according to §63a AMG which includes the following in absence of the Graduated Plan Officer:
Ensuring an adequate quality management system to fulfill all relevant pharmacovigilance obligations of Dr. Evaluation of potential drug risks with simultaneous continuous updating of the benefit-risk assessment, if necessary with the involvement of a consultant human physician
Updating the action plan and its monitoring and compliance
Coordination of a step-by-step plan procedure with the competent federal authority, the supervisory authorities and, if applicable, competent associations such as BPI (German Pharmaceutical Industry Association), BAH (German Association of Pharmaceutical Manufacturers) and VfA (Association of Research-Based Pharmaceutical Companies)
Responsibility as Deputy EU/UK QPPV which includes the following in absence of the EU/UK QPPV:
Creation and maintenance of the Pharmacovigilance System Master File (PSMF) of Dr. Ensuring the required quality of all pharmacovigilance data
Transmission of information in connection with the benefit-risk assessment of Dr. Overview of periodic reconciliations with partners and subsidiaries as well as internal reconciliations with the Quality and Medical Scientific Affairs departments
Carrying out a continuous assessment of the benefit-risk profile as part of signal management
Preparation of risk management plans including the coordination of risk-minimizing measures
Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents
Several years of management experience
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
Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
Comprehensive onboarding and mentoring program
We look forward to receiving your application via our online portal.