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Pharmacovigilance Officer
2 semanas atrás
1422 Mylan, Lda.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Pharmacovigilance Officer role will make an impact:
**Core Job Responsibilities**:
- Collect, assess, process and follow-up of incoming ICSRs (Individual Case Safety Reports) and special situation reports, from any source and for all product types (medicinal products, medical devices, cosmetics, food and food supplements). Maintain a log system for the tracking of ICSRs;
- Communicate with local authorities on safety related issues, as applicable;
- Perform and ensure safety data exchange with external partners and reconciliations, according to applicable safety agreements. Ensure that Urgent Reporting Obligations are followed;
- Assist in Risk Management Plan activities;
- Perform local quality and compliance (QC) and reconciliation work. Take corrective and preventive actions as needed including completion of deviation forms (PIFs), tracking and documentation. Support Corrective Action and Preventive Action (CAPA) plans and continuous improvement work within the PV area;
- Assist in review of PV SOPs and other department’s SOPs for alignment;
- Train and support the PV team in various PV procedures, as applicable;
- Perform archiving of PV related documents;
- Actively participate in audits and inspections.
**Minimum Education**:
- Bachelor's degree or equivalent in natural sciences (preferable medical science or pharmacy)
**Minimum Experience / Training Required**:
- Prior experience of PV and case processing is desirable
- Excellent English language skills (oral and writing)
- Computer skilled
- Strong organizational skills and excellent communication skills
A t Viatris, we offer competitive salar ies, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
