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 :
- Plans the workload.
- Assigns the tasks in a timely manner.
- Organizes the planning and monitoring of one specific project.
- Checks that all files are properly handled as the day progresses and ensures that the workload is reorganized as necessary.
- Ensures the line management of Case Specialist team.
- Follows up with trainings and development plan of team.
- Performs QC and medical evaluation.
- Is accountable for the activities entrusted for the position.
- Participates in the implementation of processes related to the project.
- Local responsibilities (LPPV).
Education and Experience :
- Pharmacy Graduate / Bachelor’s degree - scientific background.
- Experience in coordinating workload and activity management.
- Min 3 years PV case processing experience is a plus.
- Experience of communicating directly with clients.
- Prior experience in a similar position is preferred.
- Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
- Knowledge of Safety databases (Safety Easy – Argus).
Skills :
- Sense of priorities.
- Organization.
- Team Spirit.
- Methodical.
- Communicant.
- Ability to make decisions.
- Rigour.
- Microsoft Office.
- Fluent in both English and French (Oral and Written).
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