Senior Area Safety Officer

Senior Area Safety Officer – French Speaker Location: Remote – European UnionContract: 12-Month Fixed-Term Contract via Kelly FSPExtension: Strong possibility of extensionLanguage: Fluent French and English required About the Opportunity: Kelly FSP is partnering with a global leader in consumer healthcare to identify an experienced Senior Area Safety Officer with strong French market expertise. This is a senior-level safety and vigilance position for an established professional who can operate with a high degree of independence across local and regional safety activities. The successful candidate will bring strong technical knowledge of vigilance requirements, combined with the confidence and maturity to engage directly with internal senior stakeholders, external partners and French Health Authorities. The role will support safety and vigilance activities across a European scope, with particular responsibility for ensuring that French market requirements are understood, appropriately managed and effectively communicated within the wider global safety organisation. This is not a purely operational or case-processing position. We are looking for someone who can take ownership, exercise sound judgement, manage stakeholders confidently and represent the safety function professionally with regulatory authorities and external partners. Key Responsibilities: French Market & Health Authority EngagementAct as a senior safety contact for the French market, providing expert guidance on local vigilance requirements and expectations.Independently manage and support interactions with French Health Authorities, including responses to requests for information, safety enquiries and regulatory communications.Maintain strong awareness of French pharmacovigilance and applicable product safety requirements, ensuring local obligations are understood and implemented appropriately.Coordinate responses to Health Authority requests, working with internal and external stakeholders to obtain accurate, timely and complete information.Support regulatory inspections, audits and Health Authority interactions, including preparation of documentation and coordination of responses.Monitor changes to French and European vigilance requirements and assess their potential operational impact. Senior Safety & Vigilance OversightProvide senior oversight of local and regional safety activities across the assigned area.Ensure vigilance processes and activities remain aligned with global procedures, local requirements and applicable quality standards.Review safety processes, documentation and operational outputs, identifying potential compliance risks and areas requiring improvement.Support the investigation of non-conformances, deviations and quality issues, contributing to appropriate CAPA development and implementation.Maintain oversight of relevant safety reporting, surveillance and reconciliation activities.Support the preparation, review and submission of applicable safety documentation and regulatory reports.Contribute to signal management, emerging safety issues and risk management activities in collaboration with global and regional safety teams.Support the maintenance and review of Pharmacovigilance System Master Files and associated documentation where applicable. Stakeholder Management & LeadershipAct as a trusted safety partner to colleagues across Medical Safety, Regulatory Affairs, Quality, Supply Chain, Commercial and other business functions.Build effective working relationships with internal stakeholders, distributors, vendors, service providers and other external partners.Provide clear and confident safety guidance to stakeholders who may not have specialist vigilance expertise.Lead discussions on safety-related issues, clearly communicating risks, requirements, actions and recommendations.Coordinate activities across multiple stakeholders and countries, ensuring ownership, timelines and deliverables are clearly understood.Represent the safety function in regional and global meetings, governance forums and project teams.Influence stakeholders appropriately where safety, quality or regulatory requirements need to be prioritised. Communication, Judgement & Problem SolvingDemonstrate sound professional judgement when assessing safety and compliance issues and determining appropriate next steps.Manage sensitive or complex safety matters with discretion, professionalism and appropriate escalation.Communicate complex regulatory and safety requirements clearly to both specialist and non-specialist audiences.Proactively identify potential issues rather than relying solely on established processes or instructions.Work independently, prioritising competing requirements and escalating issues appropriately.Develop practical solutions while maintaining patient, consumer and regulatory safety as the priority. Safety Reporting & Operational ManagementOversee and coordinate safety reporting activities, including applicable adverse event reporting and periodic safety requirements.Perform and oversee reconciliations with distributors, vendors, third parties and internal functions to ensure completeness and accuracy of safety information.Maintain oversight of literature surveillance and adverse event identification activities where applicable.Coordinate safety-related document management, records and archiving in accordance with company procedures.Support the development and delivery of safety training and awareness activities.Contribute to the development, review and implementation of local procedures, work instructions and safety processes.Support pharmacovigilance, vigilance and safety agreement activities with relevant internal and external parties. Audits, Inspections & QualitySupport inspection readiness across the assigned market and safety organisation.Participate in internal and external audits and Health Authority inspections.Coordinate and contribute to responses to audit findings and inspection observations.Support CAPA development, implementation and follow-up.Identify opportunities to strengthen compliance, quality and operational effectiveness.Ensure local practices remain aligned with global safety standards and applicable regulatory requirements. Regional & Global ProjectsParticipate in regional and global safety projects as a subject matter expert.Provide input into process improvement, system implementation and operational excellence initiatives.Support implementation of new or changing regulatory requirements across the assigned markets.Contribute to standardisation and continuous improvement of safety processes.Work effectively across international, matrixed teams and different cultural environments. Essential Experience & Qualifications: Seniority & Professional ExperienceDegree in Pharmacy, Medicine, Nursing, Life Sciences or another relevant healthcare/scientific discipline.Significant professional experience within Pharmacovigilance, Drug Safety, Product Safety or a related vigilance environment.Previous experience operating at Senior Safety Officer, Senior Pharmacovigilance, Local Safety Officer, Country Safety Officer, Area Safety Officer or equivalent level.Demonstrable experience working independently and taking ownership of local or regional safety responsibilities.Experience working within a highly regulated pharmaceutical, consumer healthcare, medical device or related environment. French Market & Regulatory Authority ExperienceFluent French, both written and spoken, is essential.Demonstrable previous experience working directly with French Health Authorities is essential.Experience independently managing or coordinating responses to French Health Authority requests, enquiries or regulatory communications.Strong un