Area safety specialist – product vigilance

Area safety specialist – product vigilance

Job Description

Our client is one of the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets.

In this role, you will be responsible for ensuring that the Local Operating Company (LOC) Safety activities for the Nordics related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any product vigilance agreements with third-party business partners. They will be responsible for having appropriate product vigilance and risk management systems in place in order to assure appropriate oversight for products within its responsibility.

Examples of tasks and areas of responsibility:
  • Provide PV support to LOC for data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g., patient support programs, market research surveys, internet sites), as applicable.
  • Ensure that day-to-day PV functions and safety activities for non-medicinal products (i.e., cosmetics, medical devices, commodities, nutritional's) are performed satisfactorily, and that regulatory compliance is maintained at Local Operating Company level.
  • Perform contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
  • Act as the local PV contact person for local PV audit and inspection.
Company Description

JobBusters is an authorized staffing and recruitment company. We are focused on white-collar workers and place great value on finding the right person for the right position. By being flexible, accessible and present in relation to the customer, consultant and candidate, we aim to find our customers 'dream candidates and our candidates' dream jobs.

  • You have 4-6 years of relevant experience within Product Vigilance.
  • You have pharmaceutical industry experience.
  • You have knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
  • You are fluent in Swedish and English, both written and oral.
  • You have knowledge of global, regional and local procedural documents as applicable
Personal qualities

You have proven ability to organize workflow activities and manage multiple critical issues, and you have excellent verbal and written communication skills. Proven ability to negotiate and communicate with internal and external customers. Ability to establish and maintain open relationships within the organization and with authorities

Admission and Application

Full time position, 40 hours per week. The position will start as soon as possible, and the assignment is expected to run until 2023-12-31. Submit your application in English today, as interviews are ongoing.
Mer info
Kontaktperson Johanna Johnsson
Telefon 072 188 33 99
Email Mejla Johanna Johnsson
Område Stockholms stad
Yrkesroll Organisation & ledning
Typ av anställning Heltid, Projekt- / Visstidsanställd
Sista ansökningsdag 16 feb 2023 (14 dagar kvar)

Om arbetsgivaren

JobBusters är ett växande personaluthyrnings- och rekryteringsföretag med lång erfarenhet. Vi samarbetar idag med allt ifrån stora globala bolag till mindre lokala företag. Vår målsättning är att hitta kundens drömkandidat och kandidatens drömjobb!