ProductLife Group is 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.