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Job DescriptionnWe are currently looking for an Area Safety Specialist to our well-known client in Solna.nnThe Area Safety Specialist is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.nnResponsibilities include but are not limited to: n- Perform regulatory monitoring for impact on vigilance activities and responsibilities.n- Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). n- Maintain oversight of proper identification of local literature articles for AE reporting as required. n- Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments within the company as applicable. n- Receive and support the Area Safety lead in the responses to safety-related health authority queries in the territory. n- Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals. n- Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements. n- Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.n- Perform other agreed tasks assigned by manager.n- Perform document management and archiving as required.n- Perform training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.n- Provide PV clauses to be included within local agreements.nnCompany DescriptionnOur client is a multinational company from the USA that operates in pharmaceuticals, health care and medical equipment. They are located in Uppsala, Stockholm and Helsingborg.nnAbout JobBustersnJobBusters is an authorized staffing and recruitment company targeting white-collar workers and was started in 2011. We at JobBusters care about our consultants and our goal is always to build long-term relationships with both consultants and clients. Our goal is always to match our clients' dream candidates with our candidates' dream jobs!nnnQualificationsn- You are a health care science professional e.g.: (nurse, pharmacist, life science degree) or equivalent training and experience.n- You have some years of relevant experience. n- You have pharmaceutical industry experience including product vigilance responsibility role.n- You have sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.?n- You are fluent in Swedish and English, both oral and written.nnWhen you join JobBustersnAs a consultant at JobBusters, you can feel secure with a collective agreement, available consultant managers and committed recruiters. As a consultant, you also get access to our network of exciting companies and clients! For us, it is important that you as a consultant feel comfortable, feel a sense of security and community with us as an employer. We offer an occupational pension, salary change and the option of flexpension. You also get access to our benefits portal, where in addition to wellness allowance you have access to lots of discounts and offers in wellnes, home and leisure, transport, healthcare and much more! Your well-being is of the highest priority for us and we offer, among other things, a digital solution that helps our employees find tools to deal with all the challenges of everyday life, both at work and in private life.nnPersonal qualitiesnYou have good verbal and written communication skills and ability to establish and maintain open relationships within the organization and with authorities.nnAdmission and ApplicationnFull time position, 40 hours per week. The position will start as agreed, and the assignment is expected to run for 1 year with the possibility of extension. For this assignment you will be employed by JobBusters as a consultant at our client in Solna, Stockholm. Remote work is possible up to 40% of the time. Submit your application in English today, as interviews are ongoing.

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