What the Associate II, Pharmacovigilance does at Worldwide
Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines / requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions. Serves as Lead PV Associate on moderate to large sized studies that are moderate to complex in scope of work with moderate support from senior staff.
What you will do
Author Safety Management Plan for assigned studies
Attend and present at Investigator Meetings
Review incoming SAE data for completeness and accuracy
Perform data entry in the Safety Database and / or complete applicable tracking of incoming safety information
Perform QC of SAEs processed by other PV Associates
Generate regulatory reports and perform safety submissions as needed
What you will bring to the role
Strong understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
Strong understanding of computer technology, and management of relational database systems, including extraction of data
Excellent organizational skills and ability to handle multiple competing priorities within tight timelines
Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities
Your experience
Minimum of 3 years of pharmacovigilance experience (pre-approval clinical trials)
Bachelor’s degree in science related field, nursing or equivalent combination of relevant education and experience
Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
Excellent written and verbal communication skills
Excellent organization skills and attention to detail
Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines
Ability to work independently, prioritize work effectively and work successfully in matrix team environment
Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and / or bid defense meeting)
Fluent in written and verbal English
Associate II, Pharmacovigilance - Brazil - Remote • São Caetano do Sul, São Paulo, Brazil
Role : Subject Matter Expert(Medical - Brazil).Rate per hour : 35 usd per hour.Time commitment per day : 4- 6 hours per day.Duration of the project: 6 months.Eligibility Criteria (Mandatory).Medica...Mostre mais
WSO2 is looking for a visionary Field CTO to join our Latin American Sales Engineering team.As a company at the forefront of API Management, Integration, and Identity & Access Management (IAM), WSO...Mostre mais
Clinical Safety Analyst III LATAM- Location: Brazil.Hybrid (3x at Vila Olimpia´s office).Intrials is a disruptive company with all the attributes that a CRO must master.We mix innovative projects w...Mostre mais
What the Associate II, Pharmacovigilance does at Worldwide Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable ...Mostre mais
Clinical Safety Analyst III LATAM- Location: Brazil.Hybrid (3x at Vila Olimpia´s office).Intrials is a disruptive company with all the attributes that a CRO must master.We mix innovative projects w...Mostre mais
A KAI é uma clínica de alto padrão, integrante da One Laudos, especializada na realização de exames de diagnóstico por imagem.Realizar hunting ativo no LinkedIn, com foco em empresas de médio e gra...Mostre mais
What the Associate II, Pharmacovigilance does at WorldwideResponsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable r...Mostre mais
What the Associate II, Pharmacovigilance does at Worldwide.Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable ...Mostre mais
Estamos em rápida expansão no mercado da América Latina e buscamos talentos locais para crescer conosco.Gerenciar a equipe de filmagem local, sendo responsável por todo o processo, desde a busca de...Mostre mais
Associate Sales Director – LATAM (Brazi).São Paulo or/and Rio de Janeiro State main focus).SVP of Revenue, LATAM based in Brazil.M USD) and closing strategic deals.We support OTAs, airlines, car re...Mostre mais
Associate Sales Director – LATAM (Brazi).São Paulo or/and Rio de Janeiro State main focus).SVP of Revenue, LATAM based in Brazil.M USD) and closing strategic deals.We support OTAs, airlines, car re...Mostre mais
WSO2 is looking for a visionary Field CTO to join our Latin American Sales Engineering team.As a company at the forefront of API Management, Integration, and Identity & Access Management (IAM), WSO...Mostre mais
A cada ano, o setor de saúde perde bilhões por falhas no faturamento.Nós somos o elo perdido que resolve esse gap com IA.POR QUE ESTA POSIÇÃO É PARA VOCÊ?.Não buscamos pessoas prontas; não saber tu...Mostre mais
Dingo Software is the global leader in predictive maintenance software for the mining industry, serving some of the world’s largest mining companies.Driving efficiency, longevity and reliability fo...Mostre mais
JoVE is the world- leading producer and provider of video solutions with the mission to improve scientific research and education.Millions of scientists, educators and students use JoVE for their r...Mostre mais
We are looking for Freelance Data Annotation Specialists with strong English proficiency to support global AI and Large Language Model (LLM) projects.This is a project-based freelancing opportunity...Mostre mais
Brazil (must currently reside in Brazil with valid Brazilian ID).Fluent Portuguese (mandatory), strong English preferred.We are seeking an experienced, crypto-savvy Managing Director to lead and ex...Mostre mais
Lead the complete ANVISA product registration lifecycle, from documentation preparation to final approval, as the primary local regulatory contact.Compile and maintain all regulatory technical file...Mostre mais
