Pharmacovigilance Coordinator

Há 23 horas

São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro

Overview Pharmacovigilance Coordinator - São Paulo-SP at Johnson & Johnson Innovative Medicine . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Learn more at All job posting locations: São Paulo, Brazil An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. You Will Be Responsible For Coordinate activities with the pharmacovigilance team to be the business partner, taking the product\'s safety profile assessment to internal teams. Ensure that systems and processes are available for collection (initial and follow-up), review, reporting and reconciliation of Adverse Events obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources. Accountable internally for ensuring that the local operation meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports. Ensuring that the local pharmacovigilance activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any pharmacovigilance agreements with third party business partners. Having an appropriate system of pharmacovigilance and Risk Management in place in order to assure appropriate oversight for products within its responsibility. Responsible for the analysis, implementation and monitoring of measures taken by the company to minimize product risks. Actively participate in internal audits and inspections of good pharmacovigilance practices. Be the backup pharmacovigilance person to local Health Authority (LSD). Qualifications / Requirements Bachelor Degree Completed in health areas; Advanced English language is required (Spanish as a differential); Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field; General knowledge on healthcare and safety Proven ability to organize workflow activities and manage multiple critical issues; Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders; Other Requirements Demonstrable knowledge of all local PV requirements and of global aspects of drug Safety Preferred experience in pharmacovigilance, not limited; By preference, a minimum of 4 + years pharmaceutical industry experience Seniority level Not Applicable Employment type Full-time Job function Health Care Provider Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Johnson & Johnson Innovative Medicine by 2x #J-18808-Ljbffr

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