ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Ivry-sur-Seine; 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 ensuring compliance with regulatory standards, managing client projects, and training junior team members. Ideal candidates have a pharmacy degree and extensive experience in the field.

Qualifications

• Minimum 5-10 years 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 in PV case processing.
• Manage larger client projects and act as the single point of contact for the client.

Connaissances

Prioritization

Team Management

Organization Skills

Communication Skills

Decision-Making Ability

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 role involves overseeing and collaborating closely with our PV team to ensure compliance with regulatory standards and accurate safety data management.

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 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 degree.
• 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).

Knowledge:

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills:

• Prioritization, team management, organization skills, team spirit, methodical approach, communication skills, decision-making ability, rigor, adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).