Head of Global Safety Product Leads - Risk & Label Management; m​/f​/d

Overview

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:
Head of Global Safety Product Leads - Risk & Label Management (m/f/d).

• 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.
• 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

• In absence of the Graduated Plan Officer, ensure 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
• 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
• 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

• 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…