Overview
Pharmacovigilance Technician (6 month contract) at Viatris. The PV Technician is responsible for the maintenance and continuous improvement of the pharmacovigilance (PV) system at the PV Department of the Spanish affiliate. Perform, plan and assist in the day-to-day work at the PV department.
Responsibilities
* Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals (medical devices, cosmetics and food supplements).
* ICSR management (for drugs, medical devices, cosmetics and food supplements) and ICSR 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; including writing local SOPs, work instructions and job aids.
* Actively participate in audits and inspections.
* Perform local quality and compliance (QC) work. Take corrective and preventive actions as needed including completion of deviation forms (PIFs), tracking and documentation. Support 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. Maintain them updated.
* Assist in CEP (Customer Engagement Program) activities, such as digital media, Market Research Programs and Patient Support Programs.
* Assist in local PSUR / ACO work.
* Responsible for being up to date with written procedures and current legal requirements and internal standards within the PV area of the products in scope.
Qualifications
* 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.
* Computer skilled.
* Strong organizational skills.
Why Viatris
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Diversity & Inclusion at Viatris
Viatris values diversity and inclusion as essential to our mission. For more information on diversity, equity and inclusion, please visit Viatris careers diversity and inclusion.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life. To learn more, please visit Viatris sustainability.
Viatris is an equal opportunity employer. All qualified applicants will receive equal consideration without regard to race, nationality, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or any other characteristic protected by law.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Engineering and Information Technology
* Pharmaceutical Manufacturing
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