Manager, Pharmacovigilance, Medical Information

• Provide oversight and governance of global pharmacovigilance activities for Samsung Bioepis biosimilars
• Act as a key Biogen PV contact for Samsung Bioepis and collaborate with Biogen and Samsung Bioepis QPPVs and local PV leadership
• Develop, improve and implement regional and local pharmacovigilance processes
• Manage and coordinate PV agreements and controlled documentation
• Oversee pharmacovigilance activities related to Organized Data Collection Programs and monitor PV and Medical Information metrics
• Contribute to global and local PV inspection and audit readiness
• Monitor the benefit-risk profile of Biogen products marketed or used through Derogatory Access Programs in France
• Collect, assess, follow up, document and quality-control pharmacovigilance cases
• Support local signal detection, non-compliant use monitoring and French Health Authority requests and reports
• Oversee local PV vendors and review local organized data collection and other programs
• Develop and deliver pharmacovigilance training
• Act as Deputy Pharmacovigilance Responsible Person and local safety expert
• Supervise and support junior associates and trainees
• Manage Medical Information requests from healthcare professionals and patients
• Oversee Medical Information vendors and contribute to standard response documents
• Support the PV and Medical Information Quality Management System, including procedures, deviations, reconciliations, quality controls and KPI monitoring
• Partner with local, regional and global stakeholders to improve PV and Medical Information processes

Requirements

• Pharm.D or M.D.
• Minimum 4 years of professional experience in Pharmacovigilance and Medical Information
• Strong knowledge of French and EU pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP)
• Demonstrated experience in pharmacovigilance and medical information
• Ability to assess safety information, benefit-risk considerations and potential product quality concerns
• Experience with pharmacovigilance case management, documentation and safety databases
• Ability to evaluate and interpret complex medical and scientific information
• Strong understanding of PV quality and compliance requirements, including audit and inspection readiness
• Excellent organizational skills, attention to detail and ability to ensure appropriate documentation, follow-up and archiving
• Strong communication and stakeholder management skills
• Ability to work effectively in multidisciplinary and cross-functional teams
• Ability to operate effectively with global teams, external partners and vendors
• Proactive, adaptable, agile and responsive approach
• Fluent in French
• Strong written scientific English, with the ability to read and prepare scientific documents, reports and communications

Core Competencies

Demonstrates expertise in Pharmacovigilance and Medical Information, with a strong understanding of French and EU regulations and Good Pharmacovigilance Practices (GVP). Capable of managing pharmacovigilance processes, ensuring compliance, and effectively collaborating with multidisciplinary teams.

Highest-signal resume keywords

• Pharmacovigilance Case Management
• French And EU Pharmacovigilance Regulations
• Good Pharmacovigilance Practices (GVP)
• Medical Information Management
• Stakeholder Management

ATS Optimization Keywords

Hard Skills

• Pharmacovigilance
• Medical Information
• Safety Databases
• Documentation
• Quality Control
• Signal Detection
• Benefit-Risk Assessment
• Audit Readiness
• Case Assessment
• KPI Monitoring

Soft Skills

• Organizational Skills
• Attention To Detail
• Communication Skills
• Team Collaboration
• Adaptability

Certifications & Qualifications

• Pharm.D
• M.D

Industry Keywords

• Pharmacovigilance Activities
• Controlled Documentation
• Organized Data Collection Programs
• Quality Management System
• French Health Authority