Manager, Pharmacovigilance and Medical Device Regulations

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• Establishing, maintaining, and continuously developing the company's pharmacovigilance system • Ensuring compliance with regulatory requirements for medical devices • Managing and contributing to all pharmacovigilance activities • Supporting inspections by national regulatory authorities • Creating and maintaining PV SOPs and templates • Performing reconciliation of AE/SAE cases • Documenting and managing PV-related deviations and CAPAs • Acting as the person responsible for medical device safety • Monitoring regulatory changes in medical device legislation • Collaborating with external notified bodies and authorities

🎯 Requirements

• Completed degree in pharmacy, medicine, natural sciences, or a comparable field of study • 3-5 years of professional experience in pharmacovigilance • Strong knowledge of EU Good Pharmacovigilance Practice (EU-GVP) requirements • Knowledge of the MDR/MPBetreibV and medical device vigilance is an advantage

🏖️ Benefits

• Competitive compensation for your work • Emphasis on work/life balance • Collaborative and team-oriented environment • Opportunities for professional growth • Diversity and Inclusion • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments