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 parttime 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.