Pharmacovigilance Manager

We are seeking a Senior Specialist – Local Pharmacovigilance to be based in Finland. This role will support Local Pharmacovigilance Service (LPVS) operational activities and all aspects of technical delivery and project management. The position will also support Medical Information operational activities, including technical delivery, compliance oversight, and project coordination. Key Responsibilities Pharmacovigilance Responsibilities Set up and manage the local pharmacovigilance system. Conduct local literature searches. Manage local Individual Case Safety Reports (ICSRs). Maintain the local Pharmacovigilance System Master File (PSMF). Support the setup of local organised data collection systems. Manage local Pharmacovigilance Agreements (PVAs). Support local adaptation and submission of PSURs and Risk Management Plans (RMPs). Support implementation of additional Risk Minimisation Measures. Review materials relating to local post-authorisation safety activities. Participate in pharmacovigilance-related audits and inspections. Attend regular project meetings in line with agreed schedules. Provide monthly PV status reports for local pharmacovigilance systems. Ensure PV training for affiliate employees, service providers, and third parties. Collaborate closely with global pharmacovigilance functions and relevant local and international stakeholders. Draft, review, and maintain pharmacovigilance procedures, including SOPs and working practices. Work closely with the designated Deputy and ensure continuity of responsibilities during planned or unplanned absences. Support additional project management activities and operational responsibilities aligned with experience and training, where required. Medical Information Responsibilities Respond to Medical Information Requests (MIRs) from multiple programmes and communication channels using approved response documentation. Ensure all MIRs are processed and documented in accordance with internal procedures, client requirements, and project working practices. Identify and document adverse events, product complaints, and quality issues in line with applicable procedures. Report adverse event information to the Pharmacovigilance department. Collaborate with internal stakeholders including Regulatory Affairs, Medical Affairs, and Commercial teams to provide scientific support when required. Participate in product, disease area, and therapeutic training activities as required by projects. Support project teams with report clarifications, metrics, KPIs, volume tracking, and compliance investigations. Escalate second-line Medical Information Requests according to project agreements. Support internal and external audits. Perform quality control reviews of MIRs to ensure compliance with project requirements and procedures. Reconcile Medical Information reports with adverse event and product quality complaint reports within agreed timelines. Support additional operational or project activities aligned with skills, qualifications, and training as required. Education University degree in Life Sciences or related discipline. Experience Minimum of two years’ experience in pharmacovigilance. Strong knowledge of pharmacovigilance legislation, regulations, and industry guidelines. Experience handling Medical Information activities is advantageous. Willingness and availability to handle Medical Information enquiries via telephone between 9am–5pm on a rota basis. Skills and Competencies Ability to train and support junior or new colleagues in daily operational activities. Ability to lead small projects with clearly defined scope and deliverables. Strong stakeholder management skills with the ability to manage internal and external relationships at operational and team lead level. Excellent written and verbal communication skills, with the ability to identify issues and propose solutions effectively. Business fluent English and fluency in the local language as appropriate. #J-18808-Ljbffr