QPPV & Alliance Office Manager (f/m/d)

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day you'll enjoy a variety of challenges, such as:

• Having oversight on Grünenthal’s global Pharmacovigilance system including infrastructure, key processes, compliance metrics
• Maintaining an in-depth knowledge of the Global Drug Safety strategy, organization and business processes in collaboration with the Head QPPV & Alliance Office
• Review of new and existing international main agreements within the Grünenthal Group (e.g. license, supply, development and quality assurance agreements) with regard to Pharmacovigilance
• Preparation, negotiation, finalization and update of Drug Safety Agreements and according to the status of medicinal products in close co-operation with the license partners as well as with all departments involved within the Grünenthal Group in collaboration with the Head QPPV & Alliance Office and the QPPV
• Input to proposals of Drug Safety Agreements between the Grünenthal Local Subsidiaries and their local contractual partners to ensure global consistency and compliance with required regulations, if requested by them
• Manage integration of newly acquired medicinal products or pharmaceutical companies in Grünenthal’s pharmacovigilance system in the context of Post-Merger Integration activities, including coordination of database and knowledge transfer, and ensuring implementation of risk minimization measures that have been agreed during the Due Diligence
• Maintenance of existing process and standard templates for Drug Safety Agreements and applicable general statements for main agreements related to Pharmacovigilance responsibilities as well as creation in collaboration with the Head QPPV & Alliance Office
• In collaboration with the QPPV and Global Quality Assurance, support inspections by competent authorities and audits performed by Grünenthal’s Pharmacovigilance partners
• Support implementation of Basic PV Training to Grünenthal employees; including updates of training materials, implementation of associated awareness campaigns, record management, compliance overview and alignment with local responsible persons for PV in affiliates to ensure consistency with Global standards

What you'll bring to the table
To make the most of this role and truly thrive, you should have:

• Advanced scientific or legal university degree
• At least 5 years of experience in Drug Safety
• Comprehensive knowledge of the legal & regulatory requirements and standards regarding GVP
• Thorough understanding of quality management systems and risk management/communication
• Very good knowledge of English (both orally and in writing)
• Operational excellence and customer focus 
• Endurance and excellence in teamwork

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