Activity leader, H/F

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

Résumé du poste

A leading company is seeking a Pharmacovigilance Specialist to oversee compliance and safety data. The role includes training junior staff, managing client projects, and ensuring regulatory adherence. Ideal candidates will have extensive experience in pharmacovigilance and strong communication skills.

Qualifications

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

Responsabilités

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

Connaissances

Prioritization skills

Team management

Organization skills

Team spirit

Methodical approach

Good communication skills

Decision-making ability

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 looking for a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The role involves overseeing and collaborating 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 cases 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 clients.
5. Monitor client KPIs.
6. Support in resolving 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 in service providers, with previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

Technical Skills

• Proficiency in Microsoft Office.
• Familiarity with PV databases (e.g., Argus, ArisG).

Knowledge

• Understanding of GVP and regulatory standards related to pharmacovigilance.

Skills

• Prioritization skills.
• Team management.
• Organization skills.
• Team spirit.
• Methodical approach.
• Good communication skills.
• Decision-making ability.
• Rigour.
• Adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (Oral and Written).