Descrição

The Pharmacovigilance department of Merck is highly engaged with the implementation of automation including artificial intelligence to reduce operational workload and evolve aspects of PV career to be relating with activities of high value. This position will be part of this transition in which a Regional Pharmacovigilance Risk Management Center is being built up in Latin America. The Regional Benefit-Risk and Local Patient Safety Scientist is directly accountable for manage safety for the assigned products allocated to them in the designated region. The tasks have to be performed in order to ensure full compliance with all global and local regulatory requirements and company standards for Benefit Risk and Signal Management, as well as communication of product-specific safety information to achieve effective safety risk mitigation and optimize the benefit-risk profile of Merck Biopharma products. Besides that, this position also supports appropriate implementation of Pharmacovigilance system in Brazilian Affiliate in close collaboration with the Local Patient Safety Officer. You will be Responsible for: As Regional Benefit-Risk Scientist – Assess individual cases and use initiative and ask the ‘right’ questions from data analysis- Demonstrate understanding of some experience of signal detection methodologies targeted to data types, populations, etc.- Ability to conduct adequate aggregate evaluation with multiple sources- Conduct basic signal detection activities like case triage, medical evaluation;- Application of statistical principles behind signals;- Conduct quantitative signal detection activities, for instance, to run database reports, collate and analyze data from varying data sources (single event/aggregate) to evaluate potential signals/issues;- Leverage signal detection tools, analyze and report medical safety issues considering the worldwide regulatory requirements;- Use MedDRA coding;- Apply current approaches to balance the benefits and risks of products;- Apply quality, efficiency, speed in developing and implementing RMPs, including risk minimization measurers.- Aggregate Reporting- Author the simple sections of the aggregate safety report(s), e.g. PBRERs, PSURs;- Contribute to moderate complexity level sections of above mentioned the report(s), e.g. in relation to BR, Signals, etc;- Analyze data from different sources and input relevant data to the report(s);- Proficiency in analytical software, e.g. Spotfire, Empirical Signal.- Contribute with safety related information that can be relayed at wider program meetings (e.g. GPT, BRAT, PVAB, etc.).- Safety input into regulatory filings and associated submission activities- Contribute with data and evidence needed for regulatory filings, e.g. risk management plan, briefing book. As Local Patient Safety Support for Brazil Work in close collaboration with the Local Patient Safety Officer to ensure appropriate implementation of the Pharmacovigilance System for Brazil following international standards, regulatory requirements and company procedures. This may include: – Participation in the daily routine of Individual Case Safety Reports (ICSRs) handling buy the local affiliate including collection, registration, translation, transmission, reporting, follow up. It also includes compliance related activities as reconciliation, quality monitoring of safety information with the relevant functions;- Training activities including own timely completion of PV trainings, provide support for appropriate training of local functions either in Basic PV or Patient Data Collection System (PDCS) procedures;- Appropriate local documentation and record retention in accordance with local legislations and company standards;- Local Aggregate Safety Report and Local Risk Management Plan processes, as applicable;- Support with Safety Data Exchange Agreements (SDEA) and Local PV Vendor management, if applicable. Who you are: – Experience in the pharmaceutical industry (approx. 5 years), preferably in an affiliate setting, in the R&D organization;- Knowledge of local and regional PV requirements;- Patient Safety and/or Clinical/ Drug Development experience;- Understanding of products in various therapeutic areas;- Experience in safety databases (i.e. ARISg);- Fluent in English and Portuguese.- Spanish will be a plus. Job Requisition ID: 209744 Career Level: D – Professional (4-9 years) Working time model: full-time Careers during Covid-19Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. US DisclosureThe Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. North America DisclosureThe Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday. Auxiliar de Engenharia Civil – Graduado em engenharia civil. Experiência em obra civil. Habilidades em excel e autocad. Residir em taubaté. Ajudante de Depósito – Irá realizar carga e descarga de caminhão, organização da mercadoria no deposito, separação de mercadoria. Ter atuado na área de Corretor de Seguros – Com experiência em seguros todos os ramos, com ênfase em automóveis, residencial, vida, saúde e odonto empresarial. Essa mensagem de denúncia que você nos enviar nos ajudará a detectar ofertas ilegais por seu conteúdo ou que minam a integridade das pessoas. 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