Global Patient Safety & Quality Compliance Lead

Karo Healthcare; Stockholms kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

Karo Healthcare in Sweden is seeking a Global Patient Safety Compliance & Quality Specialist to strengthen our international pharmacovigilance and quality processes.

You will coordinate PVAs, support QA processes, and ensure regulatory compliance across EU and non-EU submissions, working with teams in Stockholm, Oslo or Warsaw.

The ideal candidate holds a life sciences degree, at least two years in pharma, and fluent English; Nordic languages are a plus, with experience in Veeva a bonus.

Qualifications

• Bachelor’s degree in life sciences or equivalent is required.
• Minimum 2 years of experience in the pharmaceutical industry.
• Fluent in English; Nordic language skills are a plus.

Responsibilities

• Coordinate Pharmacovigilance Agreements (PVAs) and oversee PVA Overview tracker.
• Act as process owner for assigned quality and compliance processes within Karo Healthcare.
• Track compliance for competent authority submissions to non-EU countries.
• Review and approve deviations, CAPAs and change controls related to GVP activities.
• Manage and archive quality and compliance documentation in line with PV Quality System.
• Support EU & UK QPPVs in maintaining PV system oversight.
• Collaborate cross-functionally to improve existing processes and establish new routines.
• Be responsible for reconciliation activities with Partners inside and outside Europe.

Skills

English fluency

Communication skills

Organizational skills

Independent work

Education

Bachelor's degree in pharmacy, Medicine, or related Life Science

Tools

Microsoft Office

Veeva

Job description

Karo Healthcare in Sweden is seeking a Global Patient Safety Compliance & Quality Specialist to strengthen our international pharmacovigilance and quality processes.

You will coordinate PVAs, support QA processes, and ensure regulatory compliance across EU and non-EU submissions, working with teams in Stockholm, Oslo or Warsaw.

The ideal candidate holds a life sciences degree, at least two years in pharma, and fluent English; Nordic languages are a plus, with experience in Veeva a bonus.