PV Compliance Officer
il y a 23 heures
PV Compliance Officer (H/F) Location: GIF-SUR-YVETTE, FranceContract type: CDI (Full‑time)Job ID: 9895 Servier France is an international, independent pharmaceutical group focused on therapeutic progress for patients. We are seeking a PV Compliance Officer to join our PV Systems and Tools unit within the Global Safety Department. Responsibilities Maintain and improve the quality, performance, and compliance of operational PV activities. Monitor KPIs and compliance metrics, and develop relevant KPIs in collaboration with the technical team. Lead audit and inspection readiness activities, including preparation and participation in interviews with third parties and health authorities. Investigate and document late submissions of PV reports (ICSR, Aggregate Reports, ESI, etc.) and monitor the timely exchange of information with business partners. Generate, review, and distribute compliance and quality metrics and trending analyses. Coordinate compliance, quality, and process improvement initiatives and provide input into CAPAs, measuring their effectiveness. Escalate compliance issues related to global PV obligations to senior management. Identify potential quality failures and initiate corrective measures as needed. Partner with key stakeholders to ensure robust corrective actions and effective checks are implemented. Collaborate with stakeholders to ensure metrics are fit for oversight purposes and meet regulatory expectations. Develop, review, and validate metrics presentations, visualizations, and reports ensuring clarity and usability. Maintain quality documents related to PV activities ensuring alignment with regulatory requirements and internal policies. Report periodically on PV activities to direct line manager. Identify and mitigate risks related to PV compliance, processes, or resources. Contribute to preparing and monitoring inspections and audits conducted by business partners and regulatory authorities. Qualifications Pharmacist, scientist, life‑science graduate, data analyst, or quality graduate with PV experience. Minimum 5 years of experience in the pharmaceutical industry in PV, with at least 3 years in case processing on an international perimeter or in PV quality and data analysis. Excellent knowledge of Global PV regulatory requirements (ICH, GVP, FDA, and other guidelines). Experience in developing and delivering presentations to management. Strong IT proficiency, advanced Excel, and knowledge of safety databases (Argus, ARISg) and BI solutions is an asset. Fluency in English. Leadership skills: ability to adapt to change, manage cultural change, propose solutions, and ensure compliance with legal requirements. Servier France is committed to equal opportunity and diversity. We value both experience and the desire to contribute to therapeutic progress for patients. If you see yourself in this opportunity, we encourage you to apply. #J-18808-Ljbffr
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Pv Compliance Officer H/F
il y a 4 semaines
Gif-sur-Yvette, France Servier Temps pleinThe PV Compliance Officer is a part of PV Systems and Tools unit, belonging to Case Management and Pharmacovigilance Systems Unit within Global Safety Department. This PV Systems and Tools unit is mainly responsible for configuration and maintenance of the PV systems, especially the Global Safety Database (Argus Safety) and the Business Intelligence and...
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PV Compliance Officer
il y a 19 heures
Gif-sur-Yvette, France Servier Group Temps pleinThe PV Compliance Officer is a part of PV Systems and Tools unit, belonging to Case Management and Pharmacovigilance Systems Unit within Global Safety Department. This PV Systems and Tools unit is mainly responsible for configuration and maintenance of the PV systems, especially the Global Safety Database (Argus Safety) and the Business Intelligence and...
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PV Compliance Officer
il y a 19 heures
Gif-sur-Yvette, France Servier Temps pleinThe PV Compliance Officer is a part of PV Systems and Tools unit, belonging to Case Management and Pharmacovigilance Systems Unit within Global Safety Department. This PV Systems and Tools unit is mainly responsible for configuration and maintenance of the PV systems, especially the Global Safety Database (Argus Safety) and the Business Intelligence and...
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Senior PV Compliance Lead – Global Safety
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