Head of Global Safety Product Leads - Freiburg - Dr. Falk Pharma GmbH

Beschreibung

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

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
• Preparation of periodic safety reports
• 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

• 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

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. Falk Pharma GmbH by establishing suitable working methods and processes as well as procedural instructions for the quality assurance of results
• Collection and systematic documentation of reports on suspected cases of possible drug risks before and after receiving marketing authorization, from spontaneous reports, as part of post-marketing surveillance, from publications in the specialist literature and relevant databases. This includes the active and regular review of specialist literature and relevant databases with regard to published suspected cases of adverse drug reactions
• Fulfillment of all statutory notification and reporting obligations with regard to possible drug risks
• Evaluation of potential drug risks with simultaneous continuous updating of the benefit-risk assessment, if necessary with the involvement of a consultant human physician
• Coordination of risk prevention measures as part of the action plan
• Updating the action plan and its monitoring and compliance
• Informing the competent authority(ies) about quality defects that could lead to a recall or an unusual restriction of distribution
• Informing the competent authority(ies) of any suspicion of falsification of medicinal products or active substances
• 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)
• Ensuring that the persons responsible for pharmacovigilance at licensees/licensors, sales partners and subsidiaries are informed about identified drug risks
• Informing and advising affected company divisions

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. Falk Pharma GmbH in accordance with the requirements of EU/UK legislation
• Overview of the entire pharmacovigilance system including the establishment of suitable parameters for measuring quality (key performance indicators)
• Ensuring the required quality of all pharmacovigilance data
• Collection and reporting of suspected adverse drug reactions within the reporting deadlines specified in EU/UK legislation
• Transmission of information in connection with the benefit-risk assessment of Dr. Falk Pharma GmbH's medicinal products to the responsible EU/UK authorities
• 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
• Conducting PV training for employees of Dr. Falk Pharma GmbH, sales partners and subsidiaries
• Preparation of periodic safety reports (PSUR/DSUR)
• Preparation of risk management plans including the coordination of risk-minimizing measures
• Approval and release of PASS protocols
• Support and advice in the preparation of regulatory submissions
• Contact person for the competent EU/UK authorities on a 24/7 basis
• Contact person for GVP inspections
• Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents

Your qualification

• Successfully completed degree in pharmacy or human medicine
• Several years of professional experience in the field of pharmacovigilance
• 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

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.

HR department Dr. Falk Pharma GmbH Leinenweberstraße 5
79108 Freiburg im Breisgau