Consultant within Regulatory & Pharmacovigilance in Pharma

An exciting opportunity to join the Pharmaceutical Affairs Team at an international pharmaceutical company as a consultant. The aim of the role is to be regulatory and pharmacovigilance responsible for one of two business areas. The role is a mix of hands-on tasks, as well as ensuring general oversight and coordination of activities in area of own responsibility. There will be close collaboration with other functions such as commercial, medical and supply chain, as well as corporate regulatory and pharmacovigilance based at the head quarter. The role is based in Stockholm and reports to Head of Pharmaceutical Affairs. The Pharmaceutical Affairs team consists of 7 persons covering the areas of Regulatory, Pharmacovigilance, Quality (GDP) and Medical Information.

Key responsibilities

• Regulatory responsible for the business unit RARE, including launch planning
• Drive the local regulatory activities in line with business priorities
• Local regulatory submissions, translation coordination and artwork updates
• Local contact towards Nordic regulatory authorities
• Providing regulatory expertise to other local functions such as marketing, value & access and supply
• Coordination and local submissions of aRMM
• Pharmacovigilance input in medical and marketing projects such as non-interventional local studies, market research, webpages, etc.
• Management of SDEA and providing PV review of general agreements
• Handling of ICSRs, including coding according to MEDDRA

Extent
Full time position (60-100 %)
Expected starting date mid-august 2025
Assignment duration Aug 2025 to April 2026, possibly longer

Qualifications

• University degree in Life Science, Pharmacy or similar
• Minimum 1-2 years of experience in pharmacovigilance area
• Minimum 2-3 years of experience in Regulatory Affairs, preferably in a Nordic marketing company setting
• Fluent in oral and written English and a Nordic language