ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Toulouse; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading company in pharmacovigilance is seeking a dedicated Pharmacovigilance Specialist - Case Processing. The successful candidate will oversee compliance with regulatory standards and collaborate closely with the PV team. Responsibilities include training junior members, managing client projects, and ensuring safety data accuracy. The role requires strong organizational and communication skills, with a focus on quality control and regulatory compliance.

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

Organizational skills

Strong 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 successful candidate will oversee and collaborate 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 clients.
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. Understand client needs to meet and exceed expectations.
10. Organize team meetings as necessary.

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