Quality Assurance Consultant, PV Support

Job Description

We are looking for a Quality Assurance Consultant to provide QA support and Pharmacovigilance. You will be responsible for: 1. Handling quality deviations, incidents, and complaints, including root cause analysis and CAPA activities. Providing support in change control when required. 2. Updating, maintaining, and managing the lifecycle of SOPs and supporting KPI follow-up and Quality Management Review activities. 3. Handling administrative tasks related to Pharmacovigilance activities, including intake and registration of adverse event reports, creating case files, documenting archiving, and logging in local tracking tools. 4. Preparing monthly reports within QA, PV, and medical topics, and coordinating with external PV partners and systems. 5. Distributing and archiving updated SmPC and PIL documentation, as well as providing support in regulatory intelligence monitoring. 6. Registering and following up on training activities and training records.

Qualifications

We require: 1. Experience in operational Quality Assurance within pharmaceutical and/or medical device organizations. 2. Good working knowledge of GMP, GDP, GVP, and relevant EU regulatory requirements. 3. Exposure to Pharmacovigilance processes, particularly administrative case handling, is an advantage. 4. Ability to work independently, structured, and confidently with time-critical tasks. 5. Fluency in Swedish and very good English skills, both written and spoken.

Benefits

We offer: - Opportunities for personal and professional growth - A collaborative team environment - A focus on quality and making a difference in patients' lives - Core values of Trust, Quality, Passion, Flexibility, and Sustainability