ENGLISH SPEAKING ACTIVITY ASSISTANT

JR France; Arrondissement d'Évry; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company in pharmacovigilance is looking for a dedicated Pharmacovigilance Specialist to oversee case processing and ensure compliance with regulatory standards. The role involves training junior staff, managing client projects, and ensuring quality control in safety data management.

Qualifications

• Minimum 5-10 years experience with 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 primary contact.
• Perform Quality Control/Medical Review and support regulatory compliance.

Connaissances

Team management

Organization skills

Good communication skills

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 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 team understanding of tasks.
4. Manage larger client projects and act as the primary contact for the client.
5. Monitor client KPIs.
6. Support resolution of NC/CAPA, identify root causes, and implement improvements.
7. Perform Quality Control/Medical Review and support the team to ensure regulatory compliance.
8. Participate in audits and inspections as needed.
9. Understand client needs and ensure expectations are met and exceeded.
10. Organize team meetings as required.

Education and Experience:

• Pharmacy degree.
• Minimum 5-10 years experience with 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.
• Good communication skills.
• Decision-making ability.
• Rigour.
• Adaptability.
• Proficiency in Microsoft Office.
• Fluency in English and French (oral and written).