Regulatory & Pharmacovigilance Specialist

QRIOS Life Science is looking for a Regulatory & Pharmacovigilance Specialist for an assignment at a well-established company in the pharmaceutical industry. You will be responsible for regulatory matters and pharmacovigilance, and the role combines both operational and strategic tasks, with close collaboration with several functions and authorities. The assignment is full-time and based in Stockholm, starting in August 2025, and is expected to last until at least March 2026, with the possibility of extension.

About the Position

You will be responsible for regulatory matters as well as pharmacovigilance, and the role involves a combination of operational tasks and ensuring overall oversight and coordination of activities within the area of responsibility. There will be close collaboration with other functions such as commercial, medical, and supply chain departments, as well as regulatory and pharmacovigilance teams at the company's headquarters. The role is based in Stockholm and reports to the Head of Pharmaceutical Affairs.

Your Main Responsibilities

• Regulatory responsibility for a specific business unit, including launch planning
• Drive local regulatory activities in line with business priorities
• Local regulatory submissions, translation coordination, and updating of artwork
• Local contact responsibility towards Nordic regulatory authorities
• Provide regulatory expertise to other local functions such as marketing, value & access, and supply chain
• Coordination and local submissions of aRMM
• Pharmacovigilance input in medical and marketing projects
• Management of SDEA and conducting PV review of general agreements
• Management of ICSRs, including coding according to MEDDRA

Who Are You?

• Bachelor's degree in Life Science, pharmacy, or equivalent
• At least 1-2 years of experience in the field of pharmacovigilance
• At least 2-3 years of experience in Regulatory Affairs, preferably within a Nordic market company.
• Fluent in both spoken and written English and a Nordic language

If you are a self-driven and solution-oriented person who wants to work in a dynamic and international environment, we look forward to receiving your application!

About the Company

QRIOS Life Science is a leading consulting company specializing in delivering high-quality solutions and expertise in the Life Science sector. We work closely with our clients to understand their unique needs and deliver tailored solutions that drive innovation and success. With a strong focus on quality and commitment, we strive to be the premier partner in our industry. We are a consulting company that is not like many others, inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER!