Activity leader, H/F

JR France; Chalon-sur-Saône; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company in pharmacovigilance is seeking a dedicated Pharmacovigilance Specialist - Case Processing. The role involves overseeing a team, ensuring compliance with regulatory standards, and managing client projects. Ideal candidates will have a pharmacy background and extensive experience in pharmacovigilance.

Qualifications

• Minimum 5-10 years experience working for 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 to ensure regulatory compliance.

Connaissances

Team Management

Organization Skills

Communication Skills

Decision-Making

Adaptability

Formation

Pharmacy Graduate

Outils

Microsoft Office

PV Databases

Description du poste

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

Responsibilities

1. Serve as the key trainer for junior team members to enhance quality and expand knowledge of PV case processing.
2. Review 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 the resolution of 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 requested.

Education and Experience

• 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).
• 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 approach, good communication skills, decision-making ability, rigor, adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (Oral and Written).