Senior Area Safety Officer

IQVIA; Paris; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading pharmaceutical company in Paris is looking for a professional to ensure compliance with local regulations and oversee pharmacovigilance activities. The ideal candidate will manage relationships with health authorities, respond to safety queries, and ensure thorough training of local personnel on safety protocols. Applicants should have a degree in a healthcare discipline and a minimum of three years' experience in the industry. Strong organizational and communication skills are essential for this role.

Qualifications

• Minimum 3 years in the CRO/pharmaceutical industry with product vigilance responsibilities.

Responsabilités

• Manage vendor resources across assigned territories.
• Respond to safety-related queries from health authorities.
• Oversee safety documentation and archiving.
• Ensure local personnel are trained on safety reporting.

Connaissances

Strong organizational and workflow management skills

Proficient in safety-related IT systems

Excellent communication skills (verbal and written)

Ability to build relationships with internal teams and health authorities

Deep understanding of local and global product safety regulations

Fluent in English

Formation

Degree in a healthcare science discipline (e.g. Pharmacist, Nurse)

Description du poste

This role ensures compliance with local regulations and global procedures for pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance. The successful candidate will serve as the primary point of contact for safety matters with local health authorities and oversee safety operations.

Pharmacovigilance System Oversight

• Manage vendor resources across assigned territories.
• Support the Area Safety Head with inputs for the EEA Pharmacovigilance System Master File.
• Identify and investigate non-conformances; implement CAPAs.

Safety Management & Reporting

• Respond to safety-related queries from health authorities.
• Reconcile safety data with internal and external stakeholders.
• Oversee literature screening for AE reporting.
• Manage safety documentation and archiving.
• Ensure local personnel are trained on safety reporting.
• Monitor regulatory changes and notify authorities of safety issues.
• Submit safety reports (SAE, SUE, SUSAR, PSUR, RMP).
• Translate ICSR and PV documents as needed.

Collaboration & Strategic Support

• Contribute to global and local safety projects and initiatives.

Procedural Documentation

• Develop and maintain local procedures aligned with global standards and national regulations.

Audit & Inspection Readiness

• Support audits and inspections; respond to queries and implement CAPAs.

Vigilance Contract Management

• Manage vigilance clauses and contracts including setup revisions and reconciliations.

Business Continuity

• Ensure local business continuity plans are in place including AE reporting coverage and inspection readiness.

Education

• Degree in a healthcare science discipline (e.g. Pharmacist, Nurse).

Experience

• Minimum 3 years in the CRO/pharmaceutical industry with product vigilance responsibilities.

Skills & Competencies

• Strong organizational and workflow management skills.
• Proficient in safety-related IT systems.
• Excellent communication skills (verbal and written).
• Ability to build relationships with internal teams and health authorities.
• Deep understanding of local and global product safety regulations.
• Fluent in English.