Senior Pharmacovigilance Technician page is loaded
Senior Pharmacovigilance TechnicianApply locations Madrid-Office Barcelona-Office time type Full time posted on Posted Yesterday job requisition id R5658242 Viatris Pharmaceuticals S.L.
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 (PV) Senior Technician role will make an impact:
The PV Senior Technician is responsible for the maintenance and continuous improvement of the pharmacovigilance (PV) system at the PV Department at the Spanish affiliate. Perform, plan and assist in the day-to-day work at the PV department.
Key responsibilities for this role include:
* Communicate with local authorities on safety related issues, as applicable.
* 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.
* Train and support the PV team in various PV procedures, as applicable.
* 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.
* Actively participate in audits and inspections.
* ICSR management (for drugs, medical devices, cosmetics and food supplements).
* 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.
* Perform PV trainings of other departments and/or third parties.
* Assist in activities related to non-interventional studies.
* Assist in PSUR/ACO work at local level.
* Perform archiving of PV related documents.
* 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.
* Perform other duties as assigned.
The minimum qualifications for this role are:
* Bachelor's degree or equivalent in health science.
* Prior experience in PV of minimum 4-5 years.
* Fluent in Spanish and English (oral and writing), C1 Advanced qualification or equivalent.
* Computer skilled
* Strong organizational skills and excellent communication skills.
* Proactivity, orientation to details and team work capacities.
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.
Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.
We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.
#J-18808-Ljbffr