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Local Safety Officer

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Product Life Group

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Location:
Portugal

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

As a Local Safety Officer (LSO) for Portugal, you will support pharmacovigilance activities for PLG clients, acting as a back-up LSO and LPPV, and ensuring compliance with local regulations.

Job Responsibility:

  • Act as back-up Local Safety Officer (LSO) and LPPV for PLG clients in Portugal, serving as a 24/7 contact for local regulatory authorities and ensuring service continuity
  • Maintain and update local pharmacovigilance documentation (PSMF, SOPs, SDEA, PVA, TA) and support local PV systems
  • Receive, process, translate, and submit safety cases (ICSRs) in accordance with Portuguese legislation
  • conduct periodic reconciliations of vigilance reports
  • Provide or support local medical information services
  • monitor local literature and regulatory websites for safety updates, and report findings to clients
  • Coordinate outsourced local safety activities, support local studies and risk minimization measures, and translate/submit DSUR, PSUR, and RMP documents as needed
  • Deliver pharmacovigilance training to stakeholders (sales reps, distributors, affiliates)
  • Liaise professionally with clients, affiliates, and third-party vendors, and participate in audits/inspections
  • Flex working hours to support Brazil mailbox coverage during absences

Requirements:

  • Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, or a science-related field (or equivalent experience)
  • Minimum 2 years’ experience in pharmacovigilance
  • Experience in local PV case management and regulatory communication
  • Familiarity with Portuguese regulatory environments
  • Fluent in Portuguese (written and verbal)
  • Excellent English proficiency
  • Strong organizational and interpersonal skills
  • Excellent time management and attention to detail
  • Proficient in MS Word and Excel

Nice to have:

  • French is a plus
  • Experience with safety databases and MedDRA is desirable

Additional Information:

Job Posted:
January 10, 2026

Employment Type:
Fulltime
Work Type:
Remote work
Job Link Share:

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