Pharmacovigilance Team Lead (French Speaker)

PLG is looking for a dedicated Case Specialist Team Lead / LPPV to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.

Responsibilities:

1. Plans the workload.
2. Assigns the tasks in a timely manner.
3. Organizes the planning and monitoring of one specific project.
4. Checks that all files are properly handled as the day progresses and ensures that the workload is reorganized as necessary.
5. Ensures the line management of the Case Specialist team.
6. Follows up with training and development plans for the team.
7. Performs QC and medical evaluation.
8. Is accountable for the activities entrusted for the position.
9. Participates in the implementation of processes related to the project.
10. Local responsibilities (LPPV).

Education and Experience:

1. Experience in coordinating workload and activity management.
2. Minimum 3 years of PV case processing experience is a plus.
3. Experience communicating directly with clients.
4. Prior experience in a similar position is preferred.
5. Pharmaceutical background – strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
6. Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
7. Knowledge of Safety databases (Safety Easy – Argus).

Skills:

1. Sense of priorities.
2. Organization.
3. Team spirit.
4. Methodical.
5. Communicative.
6. Ability to make decisions.
7. Rigour.
8. Microsoft Office.
9. Fluent in both English and French (oral and written).