Senior Area Safety Officer
il y a 2 semaines
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 LOC personnel are trained on safety reporting.
- Monitor regulatory changes and notify authorities of safety issues.
- Submit safety reports (SAE, SUE, SUSARs, 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
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
-
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...
-
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...
-
Senior Safety Officer
il y a 3 heures
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...
-
Senior Project Officer
il y a 2 jours
Paris, Île-de-France UNESCO Temps pleinOVERVIEW Post Number : CI/PA 030Grade : P-4Parent Sector : Communication and Information Sector (CI)Duty Station: ParisJob Family: Communication and InformationType of contract : Project AppointmentDuration of contract : 1 yearRecruitment open to : Internal and external candidatesApplication Deadline (Midnight Paris Time) : 05-JAN-2026UNESCO...
-
Senior Project Officer
il y a 7 heures
Paris, Île-de-France unesco Temps pleinOVERVIEWPost Number : CI/PA 030Grade : P-4Parent Sector : Communication and Information Sector (CI)Duty Station: ParisJob Family: Communication and InformationType of contract : Project AppointmentDuration of contract : 1 yearRecruitment open to : Internal and external candidatesApplication Deadline (Midnight Paris Time) : 05-JAN-2026UNESCO Core Values:...
-
Safety Base Officer
il y a 1 semaine
Paris, Île-de-France EXCELYA Temps pleinWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service...
-
Office Manager
il y a 1 semaine
Paris, Île-de-France Clearwater Analytics (CWAN) Temps pleinThe Office Manager will be responsible for ensuring the efficient functioning of the office, providing administrative support to team members, and managing reception duties. This role requires a highly organised individual with strong communication skills and the ability to multitask in a fast-paced environment.Key Roles & ResponsibilitiesReception...
-
Senior Compliance Officer Advisory
il y a 2 semaines
Paris, Île-de-France Natixis Temps pleinDescriptionVous rejoignez l'équipe Compliance Banking Debt Financing (DCM/Financements structurés/ Financements d'acquisition) en tant que senior compliance officer advisory. Cette équipe assure la couverture de la conformité des activités financements infrastructure et energie, immobilier et aviation, financements d'acquisition, debt capital markets et...
-
Digital Trust and Safety Analyst Hebrew + English
il y a 6 jours
Paris, Île-de-France Essence Coaching Group Temps pleinDigital Trust and Safety Analyst Hebrew + English Are you a detail-oriented professional fluent in both Hebrew and English, seeking to advance your career in a fast-growing international environment? Join a dynamic global team in Riga and help ensure online safety, trust, and quality across digital platforms. What You'll Do Provide back-office support and...
-
Senior Press Communications Officer
il y a 1 semaine
Paris, Île-de-France Euronext Temps pleinEuronext is seeking a Senior Press Communications Officer with 3 to 5 years of professional experience in media relations to join our Press Office in Paris. The successful candidate will strengthen the team's capacity to deliver impactful communication across Corporate, French and international topics, with direct engagement with both French and...
