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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