Pharmacovigilance Case Processing Officer H/F Servier

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

Nous sommes engagés pour l'égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l'expérience qu'à l'envie de s'engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.