Activity leader, H/F

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

Résumé du poste

A leading company is seeking a dedicated Pharmacovigilance Specialist - Case Processing to oversee the PV team, ensuring compliance with regulatory standards and accurate safety data. The role involves training, process improvement, client management, and quality control. Candidates should have a pharmacy degree and extensive experience in pharmacovigilance.

Qualifications

• Minimum 5-10 years working for service providers.
• Previous experience in data entry, management, or pharmacovigilance.

Responsabilités

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

Connaissances

Sense of priorities

Team management

Organization skills

Team spirit

Methodical approach

Strong communication skills

Decision-making ability

Rigour

Adaptability

Fluent in both English and French

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. Training: Serve as the key trainer for junior team members to enhance quality and expand knowledge of PV case processing.
2. Process Improvement: Review and identify areas for improvement.
3. Expertise: Act as SME for the team, ensuring understanding of tasks by the case management team.
4. Client Management: Manage larger client projects and act as the single point of contact for the client.
5. Monitoring: Monitor client KPIs.
6. Support: Assist in the resolution of NC/CAPA, identify RCA, and implement improvements.
7. Quality Control: Perform Quality Control/Medical Review and support the team to ensure regulatory compliance.
8. Audits: Participate in audits and inspections as required.
9. Client Needs: Understand client needs and ensure expectations are met and exceeded.
10. Meetings: Organize team meetings as requested.

Education and Experience

• Education: Pharmacy graduate.
• Experience: Minimum 5-10 years working for service providers, with 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).
• Knowledge: Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

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