Global Safety Project Manager - Operations & Compliance (m/f/d)

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 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, or abuse counterfeit drugs Medical/scientific assessment of drug risks and their documentation, taking into account the legal 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 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 personal@drfalkpharma.de or call 0761 1514-253. We look forward to receiving your application via our online portal.