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 on a timely manner
* Organize the planning and monitoring of one specific project
* Check that all files are properly handled as the day progresses and ensure that the workload is reorganized as necessary
* Ensure the line management of Case Specialist team
* Follow up with trainings and development plan of team
* Perform QC and medical evaluation
* To be accountable for the activities entrusted for the position.
* Participate in the implementation of processes related to the project
* Local responsibilities (LPPV)
Education and Experience
* Experience in coordinating workload and activity management.
* Min 3 year 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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