Quality Assurance Consultant (QA with PV Support)

About this role

TFS HealthScience is a leading global mid size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service (FSP) solutions.

The Quality Assurance Consultant QA with PV support is responsible for providing hands on operational QA support and selected Pharmacovigilance administrative activities to ensure ongoing compliance with applicable regulations and internal quality systems. The role supports business continuity during periods of high workload and planned absence.

As part of our SRS FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

This is a part‑time consultancy assignment corresponding to approximately 0.4 FTE per month.

Key Responsibilities

• Operational handling of quality deviations, incidents and complaints, including root cause analysis and CAPA activities, and support in change control when required
• Update, maintenance and lifecycle management of SOPs and support in KPI follow up and Quality Management Review activities
• Administrative handling of Pharmacovigilance activities, including intake and registration of adverse event reports, creation of case files, documentation archiving and logging in local tracking tools
• Preparation of monthly reports within QA, PV and medical topics, and coordination with external PV partners and systems
• Distribution and archiving of updated SmPC and PIL documentation, as well as support in regulatory intelligence monitoring
• Registration and follow up of training activities and training records

Qualifications

• Experience from operational Quality Assurance work within pharmaceutical and or medical device organizations
• Good working knowledge of GMP, GDP, GVP and relevant EU regulatory requirements
• Exposure to Pharmacovigilance processes, particularly administrative case handling, is an advantage
• Ability to work independently, structured and confidently with time critical tasks
• Fluency in Swedish and very good English skills, written and spoken

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full service global CRO, we build solution driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.