PLG is looking for a dedicated Pharmacovigilance Activity Manager- Case Processing to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.
Responsibilities
* Key trainer for junior team members to increase quality and expand knowledge of PV case processing
* Review and identify areas of improvement
* Provide expertise and act as SME for the team, ensuring understanding of tasks by case management team
* Manage larger client projects and act as single point of contact for the client
* Monitor client KPI
* Support in the resolution of NC/CAPA, identify RCA and implement improvements
* Perform Quality Control/Medical Review and provide support to the team where necessary to ensure regulatory compliance
* Participate in audits and inspections as required
* Ensure understanding of client needs and ensure expectations are met and exceeded
* Organise team meetings as requested
Education and Experience
* Education: Pharmacy graduate
* Minimum 5-10 years experience working for service providers
* Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).
* Technical Skills: Proficiency in Microsoft Office and familiarity with PV databases (e.g., Argus, ArisG).
* Previous experience working to deadlines
* Knowledge: Understanding of GVP and regulatory standards related to pharmacovigilance.
Skills
* Sense of priorities
* Team Management
* Organization skills
* Team Spirit
* Methodical
* Communicant
* Ability to make decisions
* Rigour
* Adaptability
* Microsoft office
* Fluent in both English and French (Oral and Written)
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