Senior Area Safety Officer
il y a 1 semaine
This role ensures compliance with local regulations and global procedures for pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance. The successful candidate will serve as the primary point of contact for safety matters with local health authorities and oversee safety operations. Pharmacovigilance System Oversight Manage vendor resources across assigned territories. Support the Area Safety Head with inputs for the EEA Pharmacovigilance System Master File. Identify and investigate non-conformances; implement CAPAs. Safety Management & Reporting Respond to safety-related queries from health authorities. Reconcile safety data with internal and external stakeholders. Oversee literature screening for AE reporting. Manage safety documentation and archiving. Ensure local personnel are trained on safety reporting. Monitor regulatory changes and notify authorities of safety issues. Submit safety reports (SAE, SUE, SUSAR, PSUR, RMP). Translate ICSR and PV documents as needed. Collaboration & Strategic Support Contribute to global and local safety projects and initiatives. Procedural Documentation Develop and maintain local procedures aligned with global standards and national regulations. Audit & Inspection Readiness Support audits and inspections; respond to queries and implement CAPAs. Vigilance Contract Management Manage vigilance clauses and contracts including setup revisions and reconciliations. Business Continuity Ensure local business continuity plans are in place including AE reporting coverage and inspection readiness. Education Degree in a healthcare science discipline (e.g. Pharmacist, Nurse). Experience Minimum 3 years in the CRO/pharmaceutical industry with product vigilance responsibilities. Skills & Competencies Strong organizational and workflow management skills. Proficient in safety-related IT systems. Excellent communication skills (verbal and written). Ability to build relationships with internal teams and health authorities. Deep understanding of local and global product safety regulations. Fluent in English. #J-18808-Ljbffr
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Senior Area Safety Officer
il y a 2 semaines
Paris, Île-de-France IQVIA Temps pleinThis role ensures compliance with local regulations and global procedures for pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance. The successful candidate will serve as the primary point of contact for safety matters with local health authorities and oversee safety operationsPharmacovigilance System OversightManage vendor resources...
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Senior Area Safety Officer
il y a 2 semaines
Paris, Île-de-France IQVIA Temps pleinThis role ensures compliance with local regulations and global procedures for pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance. The successful candidate will serve as the primary point of contact for safety matters with local health authorities and oversee safety operationsPharmacovigilance System OversightManage vendor resources...
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Senior Safety Officer
il y a 2 jours
Paris, Île-de-France Excelya Temps pleinJoin Excelya, where Audacity, Care, and Energy define who we are and how we work.We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of...
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Senior Data Analyst
il y a 1 semaine
Paris, France Yubo Temps pleinGet AI-powered advice on this job and more exclusive features. Who We Are Yubo is the Social Discovery app to make new friends and hang out online. By eliminating likes and follows, we empower our users to create genuine connections and show up as their true selves. We’ve pioneered a new way for Gen Z to socialize online, and with millions of active...
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Safety Engineer
il y a 3 jours
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Senior Health
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Fr-deputy Local Safety Officer
il y a 7 jours
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Technical Safety
il y a 1 semaine
Paris, France DORIS Group Temps pleinTechnical Safety / Loss Prevention – Senior Engineer July 3, 2024 • Paris, France • Permanent DORIS is a fast-moving, technically diverse organization that drives engineering projects from feasibility to detailed design. We focus on conventional energies (Oil & Gas, LNG), renewable energies (offshore wind), and new energies (hydrogen, carbon capture)....
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Safety & Security Leader F/m - Cdi
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Paris, France IKEA Temps pleinWho you are Hej there! Are you passionate about transforming the shopping centre industry and making it an extraordinary "meeting place" experience? Well, look no further! At Ingka Centres, we're on an exciting journey to revolutionize the way people perceive shopping centres, and we're searching for someone just like you to join us in the vibrant city of...
