ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Le Mans; 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 compliance with regulatory standards, training junior team members, and managing client projects. The ideal candidate will have a pharmacy degree and extensive experience in pharmacovigilance. Join a dynamic team to ensure safety data accuracy and regulatory compliance.

Qualifications

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

Responsabilités

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

Connaissances

Prioritization skills

Team management

Organizational skills

Team spirit

Methodical approach

Effective communication

Decision-making ability

Rigour

Adaptability

Formation

Pharmacy degree

Outils

Microsoft Office

PV databases

Description du poste

Job Description:

PLG is seeking a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The successful candidate will oversee and collaborate closely with our PV team to ensure compliance with regulatory standards and maintain accurate 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 cases and identify areas for improvement.
3. Provide expertise and act as Subject Matter Expert (SME) for the team, ensuring team members understand their tasks.
4. Manage larger client projects and act as the main point of contact for clients.
5. Monitor client KPIs.
6. Support in resolving NC/CAPA, identify root causes, 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. Understand client needs and ensure expectations are met or exceeded.
10. Organize team meetings as needed.

Education and Experience:

• Pharmacy degree.
• Minimum 5-10 years of experience working with 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:

• Prioritization skills.
• Team management.
• Organizational skills.
• Team spirit.
• Methodical approach.
• Effective communication.
• Decision-making ability.
• Rigour.
• Adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).