Pharmacovigilance Case Processing Officer

Pharmacovigilance Case Processing Officer Servier Gif-sur-Yvette, France The PV Case Processing Officer handles responsibility for the management of pharmacovigilance cases subcontracted to a vendor from collection to submission Main responsibilities: Monitoring Outsourced Activities & Case Management: Manage pre- and post-marketing pharmacovigilance cases processed by Service provider: book-in, data entry, coding, narratives, quality control, medical review, and submission of applicable cases; Ensure compliance with regulatory requirements, Safety Data Exchange Agreements (SDEA), and internal procedures; Perform weekly quality control of cases processed by vendors; Draft and validate deviation forms, root cause analysis, and CAPAs for cases submitted late to Regulatory authorities and other applicable recipients. Clinical Trial Support & Documentation: Review protocols and electronic case report forms (eCRFs); write Safety Management Plans (SMP) for clinical trials; Request updates for ARGUS database configurations (studies, products, reporting rules, etc.); Provide necessary documentation and training to vendors to ensure high-quality outsourced activities. Coordination & Oversight: Perform reconciliation with business partners, Local Pharmacovigilance teams (LPVs), and clinical databases; Participate in study kick-off/end meetings, operational meetings with vendors/business partners, and in audits/inspections as a Subject Matter Expert (SME); Contribute to process optimization, quality document writing, and the validation of vendor invoices. Required skills & experience: Education: Healthcare professional or scientific background (e.g., Pharmacy, Medicine, or Life Sciences); Experience: Minimum of 4 years of experience in pharmacovigilance case management within an international environment. Hard skills: Regulatory Knowledge: Excellent understanding of global pharmacovigilance (PV) regulatory requirements; Technical: Proficient in pharmacovigilance databases (e.g., ARGUS) and other relevant safety information systems. MS office suite and other relevant tools; Literature review: Understanding of the literature surveillance process; Quality Management: Skilled in quality control, CAPA drafting, and setting/reviewing Key Performance Indicators (KPIs); Tools: Mastery of MS Office Suite and internal safety tools; Languages: Fluent in English (both spoken and written); Vendor oversight: Setting up/Reviewing key performance indicators to follow outsourced activities. Leadership skills: Onboarding & Mentorship: Capacity to onboard new collaborators and provide necessary training and documentation to case processing vendors and LPVs; Audit and inspections: Serve as a Subject Matter Expert (SME) for assigned activities/processes. Soft skills: Cross-functional Collaboration: Ability to work effectively with diverse teams outside of global safety unit, and external partners; Strong Communication: Proficiency in participating in operational meetings and regular team interactions in an international environment; Organizational Skills: High level of organization to manage multiple tasks; Adaptability: Ability to contribute to process optimization. Apply Now 1 day left