ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Mérignac; 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 - Case Processing. The role involves training junior team members, managing client projects, and ensuring compliance with regulatory standards. Ideal candidates will have a pharmacy background and extensive experience in pharmacovigilance.

Qualifications

• Minimum 5-10 years of 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.
• Perform Quality Control/Medical Review to ensure regulatory compliance.

Connaissances

Team management

Organization skills

Good communication skills

Decision-making ability

Adaptability

Formation

Pharmacy graduate

Outils

Microsoft Office

PV databases

Description du poste

Job Description:

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 the accuracy of safety data.

Responsibilities:

1. Serve as the key trainer for junior team members to enhance quality and expand knowledge in 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 case management team.
4. Manage larger client projects and act as the single point of contact for the client.
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 of experience working for service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Technical Skills:

• Proficiency in Microsoft Office.
• 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.
• Good communication skills.
• Decision-making ability.
• Rigour.
• Adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).