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 the Case Specialist team.
* Follows up with trainings and development plans of the team.
* Performs QC and medical evaluation.
* To be 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.
* Minimum 3 years of 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.
* Communicative.
* Ability to make decisions.
* Rigor.
* Microsoft Office.
* Fluent in both English and French (Oral and Written).
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