Activity leader, H/F

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

Résumé du poste

A leading company in the pharmacovigilance sector is seeking a dedicated Pharmacovigilance Specialist - Case Processing. The role involves managing client projects, training junior staff, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in pharmacovigilance and a strong understanding of regulatory requirements. Fluency in both English and French is essential.

Qualifications

• Minimum 5-10 years experience in 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 single point of contact.
• Perform Quality Control/Medical Review to ensure compliance.

Connaissances

Team management

Organization skills

Good communication skills

Adaptability

Formation

Pharmacy graduate

Outils

Microsoft Office

PV databases

Description du poste

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PLG is looking for 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 the key trainer for junior team members to enhance quality and expand knowledge in 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 act as the single point of contact for the client.
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 that expectations are met and exceeded.
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

• Sense of priorities.
• Team management.
• Organization skills.
• Team spirit.
• Methodical approach.
• Good communication skills.
• Ability to make decisions.
• Rigour.
• Adaptability.
• Fluency in both English and French (oral and written).