Area Safety Specialist
Poolia Sverige AB / Chefsjobb / Stockholm
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hela Sverige Visa alla jobb hos Poolia Sverige AB i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige We are now seeking an Area Safety Specialist for a client within the healthcare industry in Stockholm. This is a full-time consulting assignment with one of our clients. Preferd start date is June 24th, and the assignment will run for one year. Selection will be made continuously.
Responsibilities
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for AE reporting as required.
• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Kenvue departments as applicable.
• Receive and support the Area Safety lead in the responses to safety-related health authority queries in the territory.
• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.
• 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.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Perform other agreed tasks assigned by manager
• Perform document management and archiving as required
• Perform training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general
• Ensure current knowledge of all relevant company procedures and training
• Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable
Your profile
Required Qualifications:
• Education: health care science professional (nurse, pharmacist, life science degree) or equivalent training and experience.
• 1-2 years of relevant experience.
• Pharmaceutical industry experience including product vigilance responsibility role.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.?
Desired Qualifications:
• Sound knowledge of medical terminology.
• Computer literate.
• Good verbal and written communication skills
• Ability to establish and maintain open relationships within the organization and with authorities
• Fluency in the national language(s) and the English language.
Om verksamheten
Poolia offers a high level of expertise in the core areas of permanent placement and temporary staffing. The permanent placement and temporary staffing services are divided into several specialist areas: Finance & Accounting, IT, Office Support, Human Resources, Sales & Marketing, Life Science & Engineering and Legal.
Another specialist area is executive recruitment through Poolia Executive Search. The Company was founded by Björn Örås in 1989, and in 2015 had just over 1,350 employees in Sweden, Finland and Germany and a turnover of SEK 757 million.
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail address is registered.
Poolia is a registered staffing agency, meaning that we comply with the requirements set by Kompetensföretagen - the Swedish Association of Staffing Agencies.
Ersättning Fast lön
Så ansöker du Sista dag att ansöka är 2024-04-16
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "71131".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Körkort För detta jobb krävs körkort.
Arbetsplats Poolia PR AB
Kontakt Julia Asplund
julia.asplund@poolia.se Jobbnummer 8584624
Observera att sista ansökningsdag har passerat.