Group 10

ProductLife Group is looking for a Local Safety Officer (LSO)-Swedish Speaker to join our dynamic team to contribute to the activities performed in the Hub:

Group 10
Responsibilities:

• Act as point of contact with local regulatory authorities, as required
• Responsible for notifying local authorities of appointment
• Responsible for keeping up to date with local regulatory requirements
• Support/Contribute to pharmacovigilance (PV) activities performed by the Medical Information &     Vigilance Pillar /the Hub in local country
• Creation and/or Maintenance of local PSMF (as required)
• Creation and maintenance of local PV system, including creation of a local SOPs and agreements
• Safety case receipt, translation, tracking and ICSR follow up.
• ICSR reporting to local regulatory authorities (outside EU)
• Local literature/journal review (as required)
• Provision or support of medical information services (as required)
• Provision of training to PV stakeholders (sales rep, distributors, affiliate), as required
• Support/coordinate/ Oversight of local studies and risk minimisation strategies
• Contribute to the production of client administrative documents, reports and tracking tools
• Liaise with client, affiliate departments and other 3rd party vendors
• To comply with client and PLG policies and procedures to meet statutory, quality and business       requirements within the overall strategy and objectives

Group 12
Education & Experience:

  • Preferably with a scientific background (or Medical secretary) and/or equivalent experience
  •  1-2 years of experience in PV – case management

Group 13
Skills

  • Swedish is essential, Danish and Norwegian (or other Nordic languages) is very desirable
  • Good organizational skills
  • Positive attitude
  • Willingness to learn (job related and software related)
  • Team player
  • Pro-active thinker
  • Stress resistant

111 Local Safety Officer- Swedish Speakers