Regulatory And Pharmacovigilance Senior Expert

Job Summary

At Fresenius Medical Care we are the global leader in kidney care committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality innovative products services and care across the entire healthcare journey. Guided by our visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 125000 employees.

Within our Care Enablement segment we develop and provide life-sustaining medical products digital health solutions and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation efficiency and sustainable growth.

Our values guide how we work:

• We Care for our patients each other and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way growing with purpose and leading kidney care with integrity and innovation

Systems Quality & Regulatory (SQR) a global function within Care Enablement ensuring Fresenius Medical Cares products meet the highest standards of quality safety and regulatory compliance throughout the entire product lifecycle. The team supports market access innovation and patient safety by driving excellence across manufacturing and supply chain overseeing post-market surveillance and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!

Your Responsibilities:

• Perform all country/region regulatory activities ensuring product conformity safety post-market surveillance and alignment with corporate SysQaRa and Quality functions
• Drive market access by preparing/adapting registration dossiers managing submissions with consultants/TPIs supporting due diligence and enabling timely compliant approvals for new and existing products
• Act as the primary regulatory key person providing strategic guidance risk assessments and updates on national/regional regulatory requirements while ensuring internal implementation and database maintenance
• Submitting notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
• Monitor evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements.
• Create and maintain local/regional registration database
• Identify regulatory and compliance risks propose mitigation strategies and track CAPAs resulting from internal or TPI audits
• Serve as PVRP or PV contact for assigned countries interfacing with authorities healthcare professionals distributors and CDS and acting as the PV lead during audits/inspections
• For countries acting as PVRP preparation of CAPAs for audit findings and process deviations collection and forwarding of AE/ADRs and completion of quarterly compliance reports; for countries acting as PV point of contact ensure preparation of CAPAs for audit findings and process deviations by the distributor and/or consultant follow up of necessary AE/ADR collection and quarterly compliance report preparations to be performed by the related TPIs/contractors.
• Performing implementation and maintenance of Pharmacovigilance Agreements

Your Profile:

• Bachelors degree in Pharmacy Chemistry Biology Bioengineering Health Sciences or another relevant scientific discipline
• At least 5 years of professional experience in regulatory affairs and at least 2 years in pharmacovigilance
• Results-driven professional with a structured approach strong problem-solving and analytical skills and the ability to handle pressure and prioritize effectively. Excellent communicator independent worker and solution-focused in achieving quality outcomes
• Demonstrated drive for process improvement and continuous optimization
• Solid knowledge of pharmacovigilance and pharmaceutical legislation
• Proficient in English (spoken and written)

Our Offer for you:

There is a lot you can discover at Fresenius Medical Care regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together not the quickest one
• A large number of committed people with a wide range of skills talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium-sized company

Required Experience:

Senior IC

Key Skills

• Hr Executive Recruitment
• Internship
• AIX
• Fleet
• Information Technology Sales

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