• Are you a fluent French speaker who is looking for a fresh challenge in Patient Safety within a global CRO?
• Are you interested in playing a key role in handling and discussing French medical information with clients/patients, in a contact center environment, whilst working from home?

• Manage the receipt and processing of all AE reports. Including: data entry of safety data, review of AEs, writing patient narratives, submission of SAE reports to clients and regulatory agencies etc.
• Assist in the generation and maintenance of the PSS metrics
• Assist Data Management or clients on reconciliation of Medical information databases
• Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission
• Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed
• Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance
• Assist in the generation and maintenance of the PSS metrics
• Support preparation for client meetings and liaise with clients where appropriate.
• Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable
• Support and/or participate in audits and inspections including the preparation, as needed
• Demonstrate role-specific Core Competencies and company values on a consistent basis
• Build and maintain good PSS relationships across functional units

• High degree of accuracy with attention to detail.
• Functions as a team player.
• Good communication.
• Good written and verbal communication skills.
• Ability to work independently with moderate supervision.

• Associate Degree + 1 year safety experience* or 2 yrs relevant experience
• BS/BA + 6 months of Safety experience* or 1 year of relevant experience