Pharmacovigilance Associate
hace 2 semanas
Viatris is a leading healthcare company that empowers people worldwide to live healthier at every stage of life. As a Pharmacovigilance Technician, you will play a key role in maintaining the pharmacovigilance system at the PV Department at the Spanish affiliate.
Key Responsibilities- Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals.
- Perform ICSR management (for drugs, medical devices, cosmetics and food supplements) and CSR reconciliations with applicable stakeholders.
- Assist in review of PV SOPs and other department's SOPs for alignment.
- Directly involved in the continuous improvement work with regards to local PV procedures and tools.
- Actively participate in audits and inspections.
- Perform local quality and compliance (QC) work.
- Support Corrective Action and Preventive Action (CAPA) plans and continuous improvement work within the PV area.
- Assist in Risk Management Plan activities and Direct Healthcare Professional Communications (DHPC).
- Identify, negotiate and establish the applicable pharmacovigilance agreements.
- Assist in CEP (Customer Engagement Program) activities.
- Bachelor's degree or equivalent in health science.
- Prior experience in PV and case processing of minimum 1-2 years.
- Fluent in Spanish and English (oral and writing), C1 Advanced qualification or equivalent.
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Pharmacovigilance Associate
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Madrid, Madrid, España Prime Vigilance Ltd A tiempo completoJob SummaryPrimeVigilance Ltd is seeking a skilled Pharmacovigilance Associate to join our team. As a key member of our ICSR Management unit, you will be responsible for ensuring effective cooperation with clients in the area of ICSR Management.Key ResponsibilitiesProcessing Individual Case Safety Reports (ICSRs) from all sources in compliance with...
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Regulatory Intelligence and Analytics Expert
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Pharmacovigilance Associate
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Pv Associate
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hace 3 meses
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Pv Associate
hace 5 meses
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Pv Associate
hace 5 meses
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hace 1 mes
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