About Company:
Navitas Life Sciences is a global Clinical Research partner with over 35 years of expertise in Clinical, Regulatory, Safety, and Data Management solutions. We accelerate innovation in healthcare by combining deep industry knowledge, cutting-edge technology, and a client-first approach to deliver tailored solutions that improve patient outcomes and streamline drug development. With a rich portfolio of industry-leading networks, including pvnet, pvconnect, and labelnet, we empower pharmaceutical, biotechnology, and non-profit organizations, as well as US Federal Agencies, in advancing clinical research and ensuring patient safety at every stage of development. Recognized by top analyst firms like IDC Market Scape and Everest Group, we have been acknowledged for our excellence in drug safety services, clinical development platforms, and life sciences operations. Our proprietary solutions, including pharma READY and safety READY, alongside our One Clinical platform leveraging AI and machine learning, are transforming clinical trials with near real-time data and analytics that enhance trial efficiencies and outcomes. Operating across 8 offices in 5 countries, we are backed by H.I.G. Capital and continuously drive industry advancements, always keeping patients at the heart of everything we do. At Navitas Life Sciences, we believe in Powering Possibilities, enabling life-changing treatments to reach patients faster, safer, and more effectively.
Vacancy Details:
Job Description:
Dear Freshers!!!
We have an Exciting Opportunity for you as TRAINEE DRUG SAFETY ASSOCIATE.
We Are Hiring!
Trainee -Drug Safety Associate
Experience: – Freshers (Immediate Joiners)
Location: Bangalore (WFO)
Qualification: Pharma/ Life science Degree
Skills: Excellent Communication PV knowledge
Responsibilities & functions:
Individual Case Safety Report (ICSR)
Responsible for Data entry services
Undergo Trainings, Mentoring and successfully complete sign off for Data entry.
Responsible for data entry of individual case safety reports (all case report types) into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
Process all cases to meet timelines as per prioritization with defined quality and productivity in order to meet the project SLAs/KPIs.
Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
Responsible for writing and /or checking for correctness and completeness of the medically relevant safety narrative in chronological order.
Responsible for checking the completeness and accuracy of the data entered in the various fields.
Perform self-quality check before routing the case to the next workflow.
Source document preparation and archival will be done as required.
Performing necessary changes in the demoted/back routed cases from Quality reviewer/ Medical reviewer.
Addressing case corrections for any internal/external findings post case locking.
Generate follow up queries where necessary.
Maintain Knowledge of global health authority regulations and requirements
Support the team with other additional tasks as needed.
Reviewing the QR feedback received and if necessary, ensure that the feedback comments were addressed.
Co-ordinate with other workflows as required.
Support leads/manager on operational activities as needed.
How to Apply?
Please revert if interested- roshini.m@navitaslifesciences.com
