Regulatory Specialist
Who Collaborating Centre For Int Drug Monitoring / Apotekarjobb / Uppsala
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hela Sverige Visa alla jobb hos Who Collaborating Centre For Int Drug Monitoring i Uppsala Would you like to contribute to the safer use of medicines and vaccines globally? We are looking for a Regulatory Specialist at Uppsala Monitoring Centre (UMC) to support two product portfolios which focus on regulations, guidelines, standards and norms in the area of pharmacovigilance. You will join a multicultural and dynamic environment with a clear focus to enhance patient safety globally. This is a temporary position covering parental leave.
Uppsala Monitoring Centre (UMC) is an independent, non-profit foundation and international centre for medicine safety and scientific research. The organisation is custodian of VigiBase, the WHO global database of adverse event reports related to medicines and vaccines. It is the largest database of its kind in the world. In addition to working with drug safety signal monitoring, UMC has developed WHODrug Global, which is the world's most widely used drug dictionary, and is advancing pharmacovigilance through science and innovation as well as education and communication.
UMC is governed by a board consisting of members appointed by the Swedish government and WHO and has approximately 160 employees based in Uppsala (Sweden).
What you will do
As a Regulatory Specialist in the VigiBase and Regulatory Services section, you are expected to contribute with knowledge on applicable regulations, guidelines and standards relevant to the area of pharmacovigilance, in both internal and external contexts.
You will:
- Support our Product portfolios on the appropriate application of relevant guidance and standards in the products we offer.
- Support the WHO Programme for International Drug Monitoring members in developing their own guidance for regulatory practice in pharmacovigilance.
- Provide technical support internally and externally on selected existing ICH guidelines (e.g. E2A-F, M1, M4/8, M11) and ISO standards (e.g. ISO/HL7 27953-2:2011).
- Keep yourself informed about current and new regulatory guidance in key geographical regions, such as the EU and USA, but also on internationally harmonised guidance and standards developments in pharmacovigilance.
- Support product development and life-cycle management with expert knowledge about regulatory processes, existing guidance and standards.
- Contribute content for product trainings and documentation.
- Act as second line support by answering questions related to regulatory guidelines and standards.
We are looking for a person who:
- has a B.Sc. in Life Sciences such as engineering, pharmacist, chemist or similar (Alternatively, another university degree together with extensive experience in the life sciences)
- has experience working in a regulatory environment
- is fluent in written and oral English.
It is an advantage if you:
- have specific knowledge and experience in the ICH pharmacovigilance guidelines, E2A-E2F, especially E2B.
- have knowledge about other terminologies, standards and norms in the domain, such as MedDRA, IDMP, EDQM, HL7, FHIR, etc.
As a person, we would like you to have:
- great communication skills, with the ability to explain more technical concepts to less technically skilled colleagues and users
- both the analytical skills to anticipate problems, and the pragmatic approach necessary to resolve them
- the ability to bring structure and clarity to complex problems
- commitment, drive and social skills to work with others.
Uppsala Monitoring Centre (UMC) is a centre for international service and scientific research in the field of pharmacovigilance. We are the WHO Collaborating Centre for International Drug Monitoring, and manage the technical and operational aspects of the WHO Programme for International Drug Monitoring since 1978.
As an independent, non-profit foundation, we support the World Health Organization, regulatory authorities, and other stakeholders who share our vision of advancing medicines safety. Through research and development of new scientific methods, we explore the benefits and harms of medicines for patients, and offer products and services used by health authorities and the pharmaceutical industry worldwide
UMC's working language is English. We normally apply a probationary period to new appointments.
UMC follows the collective agreements between the Swedish Agency for Government Employers and Saco-S and ST. Union representatives are Malin Zaar (Saco-S) and Jessica Avasol (ST), +46 (0)18-65 60 60.
Ersättning Fast månads- vecko- eller timlön
Så ansöker du Sista dag att ansöka är 2024-03-26
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Who Collaborating Centre For Int Drug Monitoring,
https://www.who-umc.org/ Arbetsplats Uppsala Monitoring Centre
Jobbnummer 8517333
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