Activity Leader

JR France; Saint-Brieuc; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading company in pharmacovigilance is seeking a dedicated Pharmacovigilance Specialist to oversee the PV team, ensuring compliance with regulatory standards and managing safety data. The role involves training team members, managing client projects, and performing quality control.

Qualifications

• Minimum 5-10 years of experience with service providers.
• Previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Responsabilités

• Serve as the key trainer for junior team members.
• Manage larger client projects and act as the single point of contact for clients.
• Perform Quality Control/Medical Review and support regulatory compliance.

Connaissances

Prioritization

Team management

Organizational skills

Team spirit

Methodical approach

Effective communication

Decision-making

Rigour

Adaptability

Fluency in English

Fluency in French

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 and identify areas for process improvement.
3. Provide expertise and act as SME for the team, ensuring task understanding by case management staff.
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, 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 required.
9. Ensure understanding of client needs and exceed expectations.
10. Organize team meetings as needed.

Education and Experience

• Pharmacy graduate.
• Minimum 5-10 years of experience working 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).

Knowledge

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

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