Playworker

JR France; Laval; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company in the pharmacovigilance sector is seeking a dedicated Pharmacovigilance Specialist to oversee compliance and safety data management. In this role, you will train junior staff, manage client projects, and ensure regulatory standards are met. Your expertise will be vital in enhancing quality and supporting the team in audits and inspections. Fluency in both English and French is essential for effective communication.

Qualifications

• Minimum 5-10 years experience working with service providers.
• Previous experience in pharmacovigilance (preferably 5+ years).

Responsabilités

• Serve as the key trainer for junior team members.
• Manage larger client projects and act as the single point of contact for clients.
• Perform Quality Control/Medical Review and support the team.

Connaissances

Team management

Organization skills

Good communication skills

Adaptability

Decision-making ability

Formation

Pharmacy graduate

Outils

Microsoft Office

PV databases

Description du poste

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PLG is seeking a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The role involves overseeing and collaborating closely with our PV team to ensure compliance with regulatory standards and accurate safety data management.

Responsibilities

1. Serve as the key trainer for junior team members to enhance quality and expand knowledge in PV case processing.
2. Review cases and identify areas for improvement.
3. Provide expertise and act as SME for the team, ensuring understanding of tasks by the case management team.
4. Manage larger client projects and act as the single point of contact for clients.
5. Monitor client KPIs.
6. Support in resolving NC/CAPA, identify RCA, and implement improvements.
7. Perform Quality Control/Medical Review and support the team to ensure regulatory compliance.
8. Participate in audits and inspections as required.
9. Ensure understanding of client needs and meet or exceed expectations.
10. Organize team meetings as needed.

Education and Experience

• Pharmacy graduate.
• Minimum 5-10 years experience working with service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Technical Skills and Knowledge

• Proficiency in Microsoft Office and familiarity with PV databases (e.g., Argus, ArisG).
• Experience working to deadlines.
• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

• Sense of priorities.
• Team management.
• Organization skills.
• Team spirit.
• Methodical approach.
• Good communication skills.
• Decision-making ability.
• Rigour.
• Adaptability.
• Fluent in both English and French (oral and written).