Pharmacovigilance Case Processing & QA Complaints (Hybrid)

ProPharma Group; Stockholms kommun; Hybrid; SEK 480,000 - 600,000; Full time

Job summary

ProPharma Group in Sweden is seeking support for pharmacovigilance case processing and QA product complaints activities. This role is hybrid, with two days on-site at our Malmö client site, starting as soon as possible for at least six months.

The successful candidate will review adverse event reports, perform MedDRA coding, assess seriousness and regulatory reporting requirements under EU GVP, ensure timely ICSR submissions, and collaborate with stakeholders across the organization to maintain

Qualifications

• Experience in Pharmacovigilance case processing or QA product quality complaints.
• Fluent in English; Swedish or Danish is a plus.
• Strong communication skills and attention to detail.
• Ability to follow procedures and regulatory guidelines.

Responsibilities

• Review adverse event reports and quality complaints and ensure data entry is correctly achieved within the database.
• Conduct case triage, MedDRA coding and quality checks where needed.
• Assess seriousness, expectedness, and regulatory reporting requirements in line with EU GVP.
• Ensure timely submission of ICSRs when needed.
• Ensure product complaints are documented to internal procedures and regulatory standards.
• Maintain an accurate record of data to ensure compliance with guidelines.
• Monitor complaint timelines.
• Collaborate with key internal stakeholders across the organization.
• Provide overall support to Pharmacovigilance and Quality Assurance teams.

Skills

Pharmacovigilance

Quality assurance

Communication skills

Attention to detail

English fluency

Swedish/Danish (optional)

Education

University degree in Life sciences

Job description

ProPharma Group in Sweden is seeking support for pharmacovigilance case processing and QA product complaints activities. This role is hybrid, with two days on-site at our Malmö client site, starting as soon as possible for at least six months.

The successful candidate will review adverse event reports, perform MedDRA coding, assess seriousness and regulatory reporting requirements under EU GVP, ensure timely ICSR submissions, and collaborate with stakeholders across the organization to maintain