ENGLISH SPEAKING ACTIVITY ASSISTANT

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

Résumé du poste

A leading company in pharmacovigilance is seeking a Pharmacovigilance Specialist to oversee case processing and ensure compliance with regulatory standards. The role involves training team members, managing client projects, and performing quality control. Ideal candidates will have a pharmacy degree and extensive experience in pharmacovigilance.

Qualifications

• Minimum 5-10 years experience working for service providers.
• Previous experience in pharmacovigilance (preferably 5+ years).

Responsabilités

• Serve as key trainer for junior team members.
• Manage larger client projects and act as single point of contact.
• Perform Quality Control and support regulatory compliance.

Connaissances

Team management

Organization skills

Strong communication skills

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. In this role, you 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 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. Ensure understanding of client needs and meet/exceed expectations.
10. Organize team meetings as needed.

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 and familiarity with PV databases (e.g., Argus, ArisG).
• Experience working to deadlines.

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).