Pharmacovigilance Specialist
hace 2 semanas
Viatris is 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 internal standards.
Key Responsibilities:- Monitor and manage incoming ICSRs (Individual Case Safety Reports) from various sources, including PV mailbox and other communication channels.
- Perform ICSR management and CSR reconciliations with stakeholders, ensuring timely and accurate reporting.
- Assist in reviewing and updating PV SOPs and other departmental SOPs to ensure alignment with regulatory requirements.
- Contribute to the development of local PV procedures, tools, and job aids, ensuring continuous improvement and compliance.
- Participate in audits and inspections, identifying areas for improvement and implementing corrective actions.
- Support Risk Management Plan activities, Direct Healthcare Professional Communications, and pharmacovigilance agreements.
- Collaborate with the CEP team on digital media, Market Research Programs, and Patient Support Programs.
- Assist in local PSUR/ACO work, ensuring compliance with regulatory requirements.
- Bachelor's degree in health science or equivalent.
- 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. If you're passionate about making a difference in the lives of others, join our team and discover a career that empowers you to thrive.
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Pharmacovigilance Specialist
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Barcelona, Barcelona, España Viatris Company A tiempo completoJoin Viatris as a Pharmacovigilance Specialist and contribute to the maintenance and continuous improvement of the pharmacovigilance system at the Spanish affiliate.The successful candidate will be responsible for monitoring PV mailboxes and other communication channels for incoming ICSRs on drugs and parapharmaceuticals, performing ICSR management and CSR...
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