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Manager, Pharmacovigilance and Medical Device Regulations
Sobi - Swedish Orphan Biovitrum AB (publ)Manager for Pharmacovigilance and Medical Device Compliance at Sobi, responsible for safety compliance and system development. Collaborating on regulatory inspections and managing pharmacovigilance activities.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance system management, ensuring compliance with regulatory requirements for medical devices, and maintaining strong knowledge of EU Good Pharmacovigilance Practice (EU-GVP) and medical device vigilance.
Highest-signal resume keywords
Pharmacovigilance System ManagementEU Good Pharmacovigilance Practice (EU-GVP)Medical Device SafetyRegulatory ComplianceAE/SAE Case Reconciliation
ATS Keywords
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Hard Skills
PharmacovigilanceRegulatory RequirementsSOP DevelopmentDeviation ManagementCAPA ManagementMedical Device VigilanceRegulatory Change MonitoringInspection SupportCase DocumentationCollaboration with Regulatory Authorities
Industry Keywords
Medical DevicesEU-GVPMDRMPBetreibVPharmacyMedicineNatural SciencesPharmacovigilance ActivitiesNotified BodiesRegulatory Authorities
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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