Navitas Life Sciences
🌐 Why Choose Navitas Life Sciences?
-
Be part of a global leader in life sciences and drug safety.
-
Get access to world-class training and career development opportunities.
-
Work in an environment that values precision, quality, and continuous learning.
-
Build your foundation for a rewarding career in pharmacovigilance and regulatory affairs.
🚀 Take the First Step in Your PV Career!
If you’re passionate about life sciences, eager to learn, and ready to contribute to patient safety worldwide, this is the perfect starting point.
Embark on your professional journey in pharmacovigilance with Navitas Life Sciences – where every report matters, and so does every individual. 🌍
To apply for this job email your details to roshini.m@navitaslifesciences.com.
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.