ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Rennes; 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 overseeing case processing, ensuring compliance with regulatory standards, and supporting team development. Candidates should have a pharmacy background and significant experience in the field.

Qualifications

• Minimum 5-10 years experience in pharmacovigilance or related fields.
• Experience in data entry and management.

Responsabilités

• Serve as the key trainer for junior team members.
• Manage larger client projects and act as the main contact for clients.
• Perform Quality Control/Medical Review to ensure regulatory compliance.

Connaissances

Prioritization

Team Management

Organizational Skills

Communication Skills

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 team. The role involves overseeing PV case processing, ensuring compliance with regulatory standards, and maintaining accurate safety data.

Responsibilities:

1. Serve as the key trainer for junior team members to enhance quality and expand PV case processing knowledge.
2. Review cases and identify areas for improvement.
3. Provide expertise and act as SME for the team, ensuring task understanding.
4. Manage larger client projects and act as the main contact for clients.
5. Monitor client KPIs.
6. Support in resolving NC/CAPA, identify root causes, and implement improvements.
7. Perform Quality Control/Medical Review to ensure regulatory compliance.
8. Participate in audits and inspections as needed.
9. Understand client needs and exceed expectations.
10. Organize team meetings as required.

Education and Experience:

• Pharmacy graduate.
• Minimum 5-10 years experience in pharmacovigilance or related fields, preferably with service providers.
• Experience in data entry, management, or pharmacovigilance.

Technical Skills:

• Proficiency in Microsoft Office and PV databases (e.g., Argus, ArisG).
• Ability to work under deadlines.

Knowledge:

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills:

• Prioritization, team management, organizational skills, team spirit, methodical approach, communication skills, decision-making, rigor, adaptability, proficiency in Microsoft Office, fluency in English and French (oral and written).