Senior Area Safety Officer

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 LOC personnel are trained on safety reporting.
• Monitor regulatory changes and notify authorities of safety issues.
• Submit safety reports (SAE SUE SUSARs 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

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