Product Vigilance Expert

hace 5 días

Madrid, España IQVIA A tiempo completo

We are seeking a highly motivated and experienced Product Vigilance Expert to lead and manage product vigilance activities.

**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
- ** Native Spanish speaker;**fluent in English

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.

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