Pharmacovigilance Specialist
hace 2 semanas
At Viatris, we are seeking a highly skilled Pharmacovigilance Technician to join our team in Barcelona, Spain. As a key member of our Pharmacovigilance Department, you will be responsible for maintaining and improving our pharmacovigilance system, ensuring compliance with regulatory requirements and company standards.
Key Responsibilities:- Monitor and manage incoming ICSRs (Individual Case Safety Reports) from various sources, including mailboxes and communication channels.
- Perform ICSR management, CSR reconciliations, and other related tasks with stakeholders.
- Assist in reviewing and updating Pharmacovigilance SOPs (Standard Operating Procedures) and other departmental SOPs for alignment.
- Contribute to the development of local PV procedures, tools, and documentation, including SOPs, work instructions, and job aids.
- Participate in audits and inspections, ensuring compliance with regulatory requirements and company standards.
- Perform local quality and compliance (QC) work, including tracking and documentation of deviations and corrective actions.
- 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 pharmacovigilance agreements, maintaining them up-to-date.
- Support local PSUR/ACO work and other related activities.
- Bachelor's degree or equivalent in health science.
- Minimum 1-2 years of experience in pharmacovigilance and case processing.
- Fluent in Spanish and English (oral and written), with C1 Advanced qualification or equivalent.
- Strong organizational skills and computer proficiency.
Viatris is a global healthcare company dedicated to building a diverse, inclusive, and authentic workplace. We offer competitive salaries, benefits, and career progression opportunities, as well as a commitment to sustainability and corporate social responsibility.
We are an equal opportunity employer and welcome applications from qualified candidates without regard to race, nationality, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or any other characteristic protected by local, regional, or state laws, rules, or regulations.
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