Playworker

JR France; Valence; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A leading company in the pharmacovigilance sector is seeking a dedicated Pharmacovigilance Specialist to oversee the PV team, ensuring compliance with regulatory standards. Responsibilities include training, managing client projects, and performing quality control. Ideal candidates should have a pharmacy background and extensive experience in the field.

Qualifications

• Minimum 5-10 years experience in service providers.
• 5+ years in pharmacovigilance preferred.

Responsabilités

• Train junior team members and enhance quality in PV case processing.
• Manage larger client projects and act as single point of contact.
• Perform Quality Control/Medical Review for regulatory compliance.

Connaissances

Prioritization

Team Management

Organization Skills

Communication Skills

Decision-Making Ability

Adaptability

Formation

Pharmacy Graduate

Outils

Microsoft Office

PV Databases

Description du poste

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PLG is seeking a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The role involves overseeing the 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 proper 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 issues, identify RCA, and implement improvements.
7. Perform Quality Control/Medical Review, supporting 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 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

• Prioritization, team management, organization skills, team spirit, methodical approach, communication skills, decision-making ability, rigor, adaptability.

Language Requirements

Fluent in both English and French (oral and written).