Regulatory & Pharmacovigilance Specialist

6 hours ago


Stockholm, Stockholm, Sweden QRIOS AB Full time
QRIOS Life Science söker en Regulatory & Pharmacovigilance Specialist för ett uppdrag hos ett väletablerat företag inom läkemedelsbranschen. Du kommer att vara ansvarig för regulatoriska frågor och farmakovigilans och rollen kombinerar både operativa och strategiska arbetsuppgifter, med nära samarbete med flera funktioner och myndigheter. Uppdraget är på heltid och är placerat i Stockholm med start i augusti 2025, och förväntas pågå fram till minst mars 2026, men med möjlighet till förlängning.

Om tjänsten
Du kommer att vara ansvarig för regulatoriska frågor samt farmakovigilans och rollen innebär en kombination av operativa uppgifter samt att säkerställa övergripande tillsyn och koordinering av aktiviteter inom ansvarsområdet. Det kommer att vara ett nära samarbete med andra funktioner såsom kommersiella, medicinska och supply chain-avdelningar, samt regulatoriska- och farmakovigilans-team på företagets huvudkontor. Rollen är placerad i Stockholm och rapporterar till Head of Pharmaceutical Affairs.

Dina arbetsuppgifter i huvudsak

• Regulatoriskt ansvar för viss affärsenhet, inklusive lanseringsplanering

• Driva lokala regulatoriska aktiviteter i linje med affärens prioriteringar

• Lokala regulatoriska inlämningar, översättningskoordination och uppdatering av artwork

• Lokalt kontaktansvar gentemot nordiska regulatoriska myndigheter

• Ge regulatorisk expertis till andra lokala funktioner såsom marknadsföring, value & access samt supply chain

• Koordinering och lokala inlämningar av aRMM

• Farmakovigilans-input i medicinska och marknadsföringsprojekt

• Hantering av SDEA och genomförande av PV-granskning av allmänna avtal

• Hantering av ICSRs, inklusive kodning enligt MEDDRA

Vem är du?

• Högskoleexamen inom Life Science, farmaci eller motsvarande

• Minst 1-2 års erfarenhet inom farmakovigilansområdet

• Minst 2-3 års erfarenhet inom Regulatory Affairs, gärna inom ett nordiskt marknadsbolag.

• Flytande i både tal och skrift på engelska samt ett nordiskt språk
Om du är en självgående och lösningsorienterad person som vill arbeta i en dynamisk och internationell miljö ser vi fram emot att ta emot din ansökan

Om verksamheten
QRIOS Life Science är ett ledande konsultföretag som specialiserar sig på att leverera högkvalitativa lösningar och expertis inom Life Science-sektorn. Vi arbetar nära våra kunder för att förstå deras unika behov och leverera skräddarsydda lösningar som driver innovation och framgång. Med ett starkt fokus på kvalitet och engagemang strävar vi efter att vara den främsta partnern inom vår bransch. Vi är ett konsultföretag som inte är som många andra, inspirerade av de som aldrig slutar leta efter nya lösningar. Som vi säger, QRIOS MINDS GÅR LÄNGRE

  • Stockholm, Stockholm, Sweden QRIOS AB Full time

    För att skapa framgång i läkemedelsbranschen söker vi en Regulatory & Pharmacovigilance Specialist.OmvärldenSom Regulatory & Pharmacovigilance Specialist kommer du att arbeta nära flera funktioner och myndigheter. Din roll innebär ett ansvarstagande för regulatoriska frågor, farmakovigilans och en kombination av operativa och strategiska...


  • Stockholm, Stockholm, Sweden ProPharma Full time

    Company OverviewProPharma is a leading Research Consulting Organization that has been improving the health and wellness of patients for 20 years. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Our Vision:At PharmaRelations ApS, our goal is to become the best place to work within Nordic Life Science Industry by continuously improving and becoming a better employer for each year. We strive to be a dynamic and collaborative working environment where innovation, creativity, and personal growth are encouraged.The Job Description:You will be responsible...


  • Stockholm, Stockholm, Sweden POC Full time

    Job OverviewWe are seeking a highly skilled Regulatory Compliance Specialist to oversee regulatory compliance and sustainability initiatives throughout the full supply chain, product development, and design processes. This role requires working hands-on to ensure that products meet all applicable legal, regulatory, and industry standards at every stage of...


  • Stockholm, Stockholm, Sweden Academic Work Full time

    Financial Regulatory Reporting SpecialistAbout the RoleThis is an exciting opportunity to join one of Sweden's leading banks as a Financial Regulatory Reporting Specialist. As a specialist, you will play a crucial role in optimizing processes, improving data flows, and enhancing ESG reporting capabilities.About the JobIn this role, you will be responsible...


  • Stockholm, Stockholm, Sweden Rasulson Consulting AB Full time

    Rasulson Consulting AB seeks a Regulatory Compliance Specialist to drive ESG requirements and analysis efforts. The primary focus is on ensuring compliance and efficiency through regulatory reporting and effective data management practices.Main Responsibilities:Craft ESG business needs into robust IT solutions, using analytical skills and expertise.Work...


  • Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) Full time

    About RaySearch Laboratories AB (publ)RaySearch develops innovative software solutions to improve cancer care. Our team of experts is dedicated to making a real difference in patient care.This role supports compliance with RaySearch AI processes, ensuring accurate data management and maintaining AI process and product documentation. You will work closely...


  • Stockholm, Stockholm, Sweden Varnish Software Full time

    We are seeking an experienced Financial Regulatory Specialist to join our Finance, Legal & Compliance team. The successful candidate will have a strong background in corporate law, IT, or SaaS-related law, with at least 7 years of experience.About the RoleIn this role, you will be responsible for managing all legal matters, including contract negotiations,...


  • Stockholm, Stockholm, Sweden Business Sweden Full time

    About UsBusiness Sweden is a government agency working to increase export opportunities for Swedish businesses. We provide strategic advice and hands-on support to companies of all sizes and in a wide range of industries, both locally and internationally.About the RoleWe are seeking a highly skilled International Regulatory Affairs Specialist to join our...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    Company Overview:Bondi Chefrekrytering AB is a leading Swedish medtech company with high potential, committed to innovation and excellence.Job Summary:We are seeking a highly skilled Senior RA Specialist Med Tech to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with laws and regulations...


  • Stockholm, Stockholm, Sweden ProPharma Full time

    About the OpportunityAs a Regulatory Writing Specialist at ProPharma, you will play a critical role in creating high-quality regulatory documents that support the development and approval of new therapies. You will work closely with cross-functional teams to ensure that all documentation is accurate, complete, and compliant with relevant regulations. If you...


  • Stockholm, Stockholm, Sweden Raysearch Laboratories Ab (publ) Full time

    RaySearch Laboratories Ab (publ) develops cutting-edge software solutions to improve cancer treatment. With over 400 employees, we are a leading company in the field of radiation therapy. Our team is dedicated to delivering exceptional results and improving the lives of cancer patients.We are looking for a skilled QA/RA Specialist to join our team. As a...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    About the JobThe ideal candidate will have experience in compliance-related roles, preferably in the insurance or reinsurance industry, and a strong understanding of local regulations and requirements. They will also possess excellent communication skills, with the ability to communicate effectively with internal and external stakeholders at all...


  • Stockholm, Stockholm, Sweden Raysearch Laboratories Ab (publ) Full time

    RaySearch Laboratories Ab (publ) is a leading developer of software solutions for radiation therapy. Our mission is to deliver exceptional results and improve the lives of cancer patients.We are seeking a skilled QA/RA Specialist to join our team. As a QA/RA Specialist, you will be responsible for managing projects related to our Quality Management System...


  • Stockholm, Stockholm, Sweden Ericsson GmbH Full time

    Job DescriptionThis role focuses on ensuring regulatory compliance and safety standards are met for our radio products. The successful candidate will have experience in testing and standards related to EMC, Safety, RF, and regulatory approval handling for different markets.About the RolePrepare and support projects during verification and certification...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    Job Description:The Senior RA Specialist Med Tech will play a critical role in ensuring the company's medical devices comply with relevant regulations and laws.Main Responsibilities:Responsible for regulatory strategy, guidance to the organization on regulatory affairs matters throughout the life cycle of a medical device.Acting as the Regulatory Affairs...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Sr Director Regulatory AffairsCompany Overview:We are PharmaRelations ApS, a cutting-edge leader in the consumer health space, expanding into the pharmaceutical industry. Our mission is to make health solutions accessible through innovative leadership.Job Description:You will take ownership of regulatory activities across a range of areas, including MAs...


  • Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) - Stockholm Full time

    Career OpportunityWe are seeking a highly motivated and experienced QA/RA Specialist to join our team. As a key member of our department, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.Responsibilities:Manage the transition of our Quality Management System (QMS) from one digital platform to another.Coach...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Qualifications- Educational Background: Experience as a Dentist, Dental Technician, Dental Hygienist, or Dental Nurse or other equivalent dental experience.- Industry Experience: Proven experience in medical device manufacturing or production, with adherence to GMP and GDP standards.- Regulatory Knowledge: Strong understanding of ISO 13485, ISO 14971, and...


  • Stockholm, Stockholm, Sweden Raysearch Laboratories AB (Publ) Full time

    Job DescriptionWe are seeking a highly skilled QA/RA Specialist to join our team. As a key member of our Quality Assurance and Regulatory Affairs department, you will play a crucial role in ensuring the accuracy and reliability of our medical device software. Your primary responsibilities will include managing QMS transitions, CAPA processes, and...