ENGLISH SPEAKING ACTIVITY ASSISTANT

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

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Pharmacovigilance Specialist - Case Processing to oversee compliance and safety data accuracy. The role involves training junior team members, managing client projects, and ensuring regulatory standards are met. Ideal candidates will have extensive experience in pharmacovigilance and proficiency in relevant databases.

Qualifications

• Minimum 5-10 years experience in 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/Medical Review and ensure compliance.

Connaissances

Team Management

Communication

Decision-Making

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:

• Serve as the key trainer for junior team members to enhance quality and expand knowledge of PV case processing.
• Review cases and identify areas for improvement.
• Provide expertise and act as SME for the team, ensuring understanding of tasks by case management team.
• Manage larger client projects and act as the single point of contact for clients.
• Monitor client KPIs.
• Support in resolving NC/CAPA issues, identify RCA, and implement improvements.
• Perform Quality Control/Medical Review and support the team to ensure regulatory compliance.
• Participate in audits and inspections as required.
• Ensure understanding of client needs and meet or exceed expectations.
• 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).

Knowledge:

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills:

• Sense of priorities, team management, organization skills, team spirit, methodical approach, communication skills, decision-making ability, rigor, adaptability.
• Fluent in both English and French (oral and written).