Manager, Pharmacovigilance, Medical Information

Jobtailor; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Jobtailor in Paris seeks a Pharmacovigilance and Medical Information lead to oversee global PV activities and collaborate with Biogen and Samsung Bioepis leadership.

The role covers PV process improvement, case management, documentation, and audit readiness, with a focus on French regulations and EU GVP compliance. Fluent French and strong English technical writing are essential.

Qualifications

• Pharmacovigilance and Medical Information experience required.
• Fluent in French; strong written English for scientific documents.

Responsabilités

• Provide oversight and governance of global pharmacovigilance activities.
• Act as a key PV contact for Samsung Bioepis and collaborate with Biogen PV leadership.
• Develop, improve and implement regional and local PV processes.
• Manage and coordinate PV agreements and controlled documentation.
• Oversee PV activities related to Organized Data Collection Programs and monitor PV metrics.
• Contribute to PV inspection and audit readiness.
• Monitor benefit-risk profile for products in France.
• Collect, assess, follow up, document and quality-control PV cases.
• Support local signal detection, and respond to Health Authority requests.

Connaissances

Pharmacovigilance

Medical Information

Safety Databases

Documentation

Quality Control

Signal Detection

Benefit-Risk Assessment

Audit Readiness

Formation

Pharm.D

M.D.

Outils

PV case management system

Quality Management System

Description du poste

• 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