ProductLife Groupis a global provider of outsourcing and consulting services for the life sciences industry.
We help clients navigate complex regulatory environments and ensure compliance across pharmacovigilance, regulatory affairs, and medical information.
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.
Responsibilities
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.
Experience & Skills
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.
French is a plus.
Strong organizational and interpersonal skills.
Excellent time management and attention to detail.
Proficient in MS Word and Excel.
Experience with safety databases and MedDRA is desirable.