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 SERM - Safety Evaluation and Risk Management, who wants to learn and transform his career.
Mandatory:
English fluently
Relevant experience in pharmacovigilance or drug development
Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
Responsabilities:
Responsible for signal detection and evaluation activities for assigned products.
Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
Authors regulatory periodic reports (PSUR/DSUR/PBRER) and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
Acts as a member of a process improvement initiative team within GCSP.
Completes any post audit/inspection activities within the required timeline
Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of SERM physician.
Supports safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
What can you expect from us?
• Professional development and constant evolution of your skills, always in line with your interests.
• Opportunities to work outside Brazil
• A collaborative, diverse and innovative environment that encourages teamwork.
What do we offer?
TCS Benefits – Brazil:
Health insurance
Dental Plan
Life insurance
Transportation vouchers
Meal/Food Voucher
Childcare assistance
TotalPass
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
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!