Pharmacovigilance Inspector GVP

Would you like to make a vital difference for the health of people and animals? Come and work with us at the Medical Products Agency!

If you currently work in the pharmacovigilance area and want to utilize your expertise in a new context, then the role of inspector might be suitable for you.

The unit for inspection of industry and healthcare is responsible for supervising clinical trials, manufacturing, distribution, and systems for drug safety monitoring. The supervision covers actors in industry and healthcare and is mainly conducted through field inspections both nationally and internationally. We also actively participate in the development of regulations and guidelines in the respective areas. Currently, 40 people work in the unit divided into four groups: inspection GMP/GDP, inspection GVP/GCP, inspection healthcare-related production, and inspection secretariat.

We are now looking for an additional inspector to our team of pharmacovigilance inspectors within the Inspection GVP/GCP group.

Pharmacovigilance inspections are carried out to ensure that pharmaceutical companies holding marketing authorizations for drugs in the EU meet the requirements for drug safety monitoring established in regulations and guidelines. During an inspection, the company's procedures and systems for this safety monitoring, as well as the company's collected data, are reviewed. The inspection starts based on requested submitted documentation and is followed by an on-site inspection at the company. At the end of the inspection, the outcome is summarized orally, and the result is then presented in a written inspection report. The position involves some travel.

As a new inspector, you will receive a solid introduction to inspection work tailored to previous experience, and gradually, you will become more actively involved in and eventually lead inspections in Sweden. After completing certification, you are expected to be able to lead an inspection team and take responsibility for planning, implementation, and reporting of inspections. With more experience, international inspection assignments for EMA (European Medicines Agency) may be included as part of the work.

The work as an inspector is varied, and the tasks also include informing about regulations in various contexts and handling incoming questions from, for example, companies and other authorities. You will collaborate with other operations within the Medical Products Agency and are expected to contribute to handling various cases and to consensus and harmonization. Based on previous experience, there are various ways to develop forward in an expert role with us, both internally and externally. There are good opportunities to participate in national and international working groups in the field. We place great value on continuously developing our knowledge, and continuous training is offered.

We are looking for someone with a higher education in natural sciences such as a pharmacist, clinical pharmacist, biomedical scientist, nurse, or equivalent. You have previous professional experience in one or more areas related to drug safety monitoring within the pharmaceutical industry, authority, or equivalent. For example, this could be experience in receiving and handling adverse event reports, or compiling and assessing safety information and drug risks, or establishing and maintaining a PSMF (Pharmacovigilance System Master File), or regulatory work in pharmacovigilance. You have good knowledge of GVP. The daily work requires very good ability to communicate verbally and in writing in both Swedish and English.

Experience in quality work, audits, or inspections is advantageous. We also prefer if you have experience working in an international environment.

We are looking for someone with a genuine interest in patient safety and quality work. You have a structured way of working and good analytical skills. You need to be able to evaluate and assess a large amount of information when planning, carrying out, and reporting inspections. You need to be able to prioritize and make independent decisions under time pressure in connection with conducting inspections. You have high integrity and are outgoing. Inspection work requires good teamwork skills, that you are receptive, open to receiving and sharing new information, and clear in your communication with others both internally and externally. You value good treatment and can handle conveying decisions. We place great importance on personal suitability.

Application deadline: 24-03-2025Employment type: PermanentAccess: According to agreementUnit: Inspection of industry and healthcare

We apply a 6-month probationary period.We value diversity and welcome applicants from different backgrounds.

At the Medical Products Agency, you have good conditions for work-life balance. We offer you, among other things, flextime, favorable vacation conditions, wellness allowance, and health promotion during working hours. To the extent that the tasks allow, there is an opportunity to work partially remotely by agreement with the manager. If you live in another location, there may be opportunities for full-time remote work.

Read more about the benefits you get with us here: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket/formaner-hos-oss

The Medical Products Agency is an emergency preparedness authority, which means that we carry out certain background checks in connection with recruitments. In case of an interview, you will need to verify your identity and present your degree certificates and relevant certificates. All permanent staff at the Medical Products Agency are mobilized within the authority.

You are welcome to contact group manager Helena Lindberg. You can also contact the union representatives Alexandra Braf, Saco, and Pia Wictor, ST. We are all available by phone 018-17 46 00 or via email [email protected].

You may not think about the Medical Products Agency so often, but we can assure you that you encounter us in your daily life. The result of what we do is noticeable at pharmacies, hospitals, at the veterinarian, and in your bathroom cabinet. This is because we ensure that you and everyone else in Sweden have access to safe and effective drugs and medical products, ranging from patches and pregnancy tests to walkers and apps. We do this by approving and granting permits, monitoring and controlling, and by providing information and advice. We who work at the Medical Products Agency are proud of our important societal mission: to contribute to the health of the Swedish people and animals. Read more about our mission and what it means to work at the Medical Products Agency here: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket

This recruitment is conducted entirely by the Medical Products Agency. We therefore refrain from telephone calls from recruitment agencies and advertising salespeople.