Case Processor (Junior)

Tata Consultancy Services; Brasil; Presencial; BRL 60 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Life insurance

Gympass

Learning portal access

International experience opportunity

Resumo da oferta

Tata Consultancy Services in Brazil is seeking a Case Processor to triage emails, perform case intake, and manage ICSR submissions in line with regulatory guidance. You will handle data entry, maintain source documents, and coordinate with internal and external stakeholders.

Requirements include advanced Spanish and pharmacovigilance experience; Oracle Argus knowledge is preferred. The role emphasizes quality, timely completions, and transition support across new activities.

Qualificações

• Advanced Spanish language proficiency.
• Knowledge/previous experience in pharmacovigilance, ICH/GCP, Clinical Data, Drug Safety and Regulatory process.
• Previous experience in submissions utilizing Oracle Argus.

Responsabilidades

• Triage all mails to identify cases.
• Perform Case Intake activity for ICSPs.
• Book-in cases from email; save source email in database (ICS sources).
• Process cases per the detailed guidance ensuring regulatory compliance.
• Perform ICSR submission activities to different geographies.
• Quality control of ICSR activities to ensure regulatory compliance.
• Maintain open communication with stakeholders and participate in process improvements.
• Assist in transitions for new scope including training activities.

Conhecimentos

Advanced Spanish

Pharmacovigilance knowledge

ICH/GCP familiarity

Clinical Data understanding

Ferramentas

Oracle Argus

Descrição da oferta de emprego

Come to one of the biggest IT Services companies in the world! Here you can transform your career!

Why to join TCS?

Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.

We are looking for a Case Processor.

In this role you will:

• Triage all the mails received in Mailbox to identify cases
• Perform Case Intake activity for ICSPs
• Book-in case/s from email; ensure that source email is saved in database (in appropriate format) as ICSR source document
• Process case as per the detailed case processing guidance document ensuring compliance to process and requlatory requirements
• Perform ICSR submission activities to different geographies
• Perform submission activities within agreed timelines with high quality with adherence to regulatory guidelines and applicable standards, and processes - utilizing Oracle Argus.
• Perform QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements
• Maintain open and timely communication; participate on special projects and process improvement initiatives
• Knowledge and experience with ICSR submission related regulatory requirements
• Regular interaction with internal stakeholders and external stakeholders
• Escalates unresolved issues appropriately as per the agreed escalation process
• Ensures that the Quality and TAT targets defined are met
• Understand the transition plan for any new scope with perspective of training related activities
• Participate in transition for new activities, new scope or new products
• Support in transition of new scope to TCS team
• Provide complete support during project transition for ICSR related activities
• Complete assigned training as per process requirement.

Mandatory Skills:

• Advanced Spanish
• Knowledge/previous experience in pharmacovigilance, ICH/GCP, Clinical Data, Drug Safety and Regulatory process
• Previous experience in submissions utilizing Oracle Argus.

What do we offer?

• Health insurance
• Life insurance
• Gympass
• TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates
• Partnership with SESC
• Reimbursement of Certifications
• Free TCS Learning Portal – Online courses and live training
• International experience opportunity
• Discount Partnership with Universities and Language Schools
• Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire
• TCS Gems – Recognition for performance
• Xcelerate – Free Mentoring Career Platform
• Tata Consultancy Services is an equal opportunity employer, our commitment to diversity & inclusion drives our efforts to provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of any socio-economic background, race, color, national origin, religion, sex, gender identity/expression , age, marital status, disability, sexual orientation or any others. We encourage anyone interested to build a career in TCS to participate in our recruitment & selection process.
• At Tata Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects each person. Our motto is Inclusion without exception.

At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer!