Activity Leader

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

Résumé du poste

A leading company in the pharmaceutical industry is seeking a dedicated Pharmacovigilance Specialist to oversee case processing and ensure compliance with regulatory standards. This role includes training junior team members, managing client projects, and supporting quality control efforts. The ideal candidate will have extensive experience in pharmacovigilance and a strong understanding of regulatory standards.

Qualifications

• Minimum 5-10 years experience working for service providers.
• Previous experience in pharmacovigilance (preferably 5+ years).

Responsabilités

• Serve as key trainer for junior team members in PV case processing.
• Manage larger client projects and serve as the single point of contact for clients.
• Perform Quality Control/Medical Review to ensure regulatory compliance.

Connaissances

Team management

Organizational skills

Effective communication

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 and working closely with our PV team to ensure compliance with regulatory standards and accurate safety data.

Responsibilities

1. Serve as key trainer for junior team members to enhance quality and expand knowledge of PV case processing.
2. Review and identify areas for improvement.
3. Provide expertise and act as SME for the team, ensuring understanding of tasks by the case management team.
4. Manage larger client projects and serve as the single point of contact for clients.
5. Monitor client KPIs.
6. Support in the resolution of 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 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).
• Experience working to deadlines.

Knowledge

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

• Sense of priorities.
• Team management.
• Organizational skills.
• Team spirit.
• Methodical approach.
• Effective communication.
• Decision-making ability.
• Rigour.
• Adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).