Navitas Hiring For Trainee Drug Safety Associate
Designation: Trainee -Drug Safety Associate
Experience: - Freshers (Immediate Joiners)
Location: Bangalore (WFO)
Qualification: Pharma/ Life science Degree
Skills:
- Excellent Communication
- PV knowledge
- ICSR
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.
How To Apply:
 |
| Navitas Hiring For Trainee Drug Safety Associate |
Post a Comment