ENGLISH SPEAKING ACTIVITY ASSISTANT

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

Résumé du poste

A leading company in the pharmaceutical sector is looking for a dedicated Pharmacovigilance Specialist - Case Processing. This role is crucial in ensuring compliance with regulatory standards and overseeing the PV team's operations. The ideal candidate will have extensive experience in pharmacovigilance and will be responsible for training junior staff, managing client projects, and ensuring the accuracy of safety data. Fluency in English and French is essential.

Qualifications

• Minimum 5-10 years of experience working for 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 single point of contact.
• Perform Quality Control/Medical Review and support regulatory compliance.

Connaissances

Team management

Organizational skills

Effective communication

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 of 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 the client.
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. Understand client needs and ensure expectations are met and exceeded.
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.
• Organizational skills.
• Team spirit.
• Methodical approach.
• Effective communication.
• Decision-making ability.
• Rigour.
• Adaptability.
• Fluent in English and French (oral and written).