BioArctic is looking for a Director of Pharmacovigilance responsible for the global drug safety and risk management strategy for investigational and Nordic marketed medicinal products, including Leqembi. You will ensure compliance with regulatory requirements and a robust safety profile across BioArctic’s clinical development portfolio.

In this role, you will partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Commercial functions to support benefit risk evaluations and safety governance. The role can be combined with project leadership or other special assignments.

What you will do

• Lead BioArctic’s Pharmacovigilance framework and maintain oversight of processes and tasks, for Leqembi and internal development projects, including alignment of medical information enquiries.

• Provide expert PV oversight of clinical development Phases I–IV.

• Drive post marketing product safety in the Nordic region.

• Serve as an internal PV expert together with the BioArctic representative by overseeing PV vendor.

What you bring

• University degree in a relevant natural science subject area.

• At least 5 years, preferably 10 years, of experience in Pharmacovigilance in the pharmaceutical industry, including both clinical trials and post marketing product safety.

Strongly desirable

• In depth knowledge of processes and regulations for the implementation of clinical development such as GCP/PVP.

• Experience in preparing benefit risk documentation and Development Safety Update Reports.

• Experience of working with CNS indications.

• Knowledge of PV regulatory requirements and experience interacting with Nordic Health Authorities.

• Very good experience in external collaborations.

• Excellent ability to communicate verbally and in writing, both in Swedish and English.

At BioArctic, our values - Care, Collaborate, Challenge - guide everything we do.

If you recognize yourself in this profile and are motivated by leading Pharmacovigilance activities and global drug safety and risk management, we would be happy to receive your application. This is a permanent, full-time position with a start date as soon as possible, located at our headquarters in Stockholm. Candidate selection and interviews are held on a continuous basis, and the advertisement may be closed before the deadline.

If you’re ready to make a real difference for patients with high unmet medical needs, apply today and join our mission.

For further information about BioArctic and our mission, please visit www.bioarctic.com.

This recruitment process is managed directly by BioArctic. We kindly decline contact from external recruitment agencies and vendors.