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Pl pharmacovigilance analyst

São Paulo (SP)
Guerbet
Anunciada dia A 14 h atrás
Descrição

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.YOUR ROLE Preparation, tracking, and submission all all Pharmacovigilance/Materiovigilance(PV/MV) case reports and special situations to Headquarters and the Local HealthAuthority (HA). Archiving all documentation related to Pharmacovigilance and Materiovigilance (casessubmitted to Headquarters, CA, trainings, e-mails, etc), according to local procedures. Request follow-up information for the completion of case reports making use of specificproduct/event-related questionnaires when necessary, including assistance in developingand mailing response letter to customers if necessary. Perform literature search and signal detection regarding adverse events related toGuerbet Products. Interface with quality assurance, customer service, commercial/sales, technicalassistance and medical related to PV/MV matters. Perform the reconciliation of PV/MV cases received with GVMI and cross-functions, suchas Customer Service, Technical Service, Medical Information Service, Commercialcolleagues and Distributors. Assist in reviewing the wording of the labeling and packaging material referring toPV/MV in accordance with current legislation. Responsible for preparing and conducting Pharmacovigilance/Materiovigilance trainingfor the Company and stakeholders. Preparation and review of Standard Operating Procedures as well as impact assessmentaligned with local legislation and global procedures. Support PV/MV compliance and KPI's. Support in PV/MV audits, according to the scope of this position. Support routine payment activities for the area (e.g. regular service providers), includinginvoice receipt, entry into the finance system, submission for approval, and relatedadministrative steps.YOUR BACKGROUND Academic background: Pharmacist, Veterinarian, Biologist, or Nurse with an activeregistration in the respective Regional Council. Fluency in English and Portuguese. At least 2 year of previous Pharmacovigilance experience. Knowledge of standard Office software packages (e.g. Word, Excel). Interface with quality assurance, customer service, commercial/sales, technicalassistance and medical related to PV/MV matters. Perform the reconciliation of PV/MV cases received with GVMI and cross-functions, suchas Customer Service, Technical Service, Medical Information Service, Commercialcolleagues and Distributors. Assist in reviewing the wording of the labeling and packaging material referring toPV/MV in accordance with current legislation. Responsible for preparing and conducting Pharmacovigilance/Materiovigilance trainingfor the Company and stakeholders. Preparation and review of Standard Operating Procedures as well as impact assessmentaligned with local legislation and global procedures. Support PV/MV compliance and KPI's. Support in PV/MV audits, according to the scope of this position. Support routine payment activities for the area (e.g. regular service providers), includinginvoice receipt, entry into the finance system, submission for approval, and relatedadministrative steps.

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