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| Job Location | Mysore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Essential Duties and Responsibilities :
This role requires fluent Italian/ Spanish / German / French / Portuguese (reading, writing, and speaking) skills to process and translate ICSRs (individual case safety reports) from Italian/ Spanish / German / French / Portuguese to English and vice versa. Also requires handling relevant data entry tasks using specific drug safety systems/database.
As case intake member:
Responsible for case intake, duplicate check and registration.
Maintain log of source documents and other communications.
As Case Processor:
Responsible for data entry of individual case safety reports into the safety database.
Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
Process all incoming cases in order to meet timelines.
Full data entry including medical coding and safety narrative.
As Medical Coder:
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).
As Narrative Writer:
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
As Quality Check Reviewer
Review data entered in safety database for completeness and accuracy.
Check the consistency of data on PERCEIVE, CIOMS, and ARISg.
Updates QC Tracker with QC results (PVMA).
Review cases requiring corrections with the corresponding DE.
Confirm labeledness and reportability assessment.
Close non-reportable and reportable cases in AgXchange OST if required.
Provide quality feedback to team resources
Track and maintain quality metrics
OTHER RESPONSIBILITIES:
Follow up on reconciliation of discrepancies.
Follow departmental AE workflow procedures.
Mentor and guide the activities of the Dug Safety Associate.
High level of proficiency at all workflow tasks.
Perform any other drug safety related activities as assigned.
SPECIALIZED KNOWLEDGE AND SKILLS :
Basic competence with medical and therapeutic terminology.
Ability to work independently but guided by documented procedures, with appropriate support.
Able to work effectively as part of a team.
Understanding of patient safety regulatory obligations.
Should be familiar with regulatory pharmacovigilance guidelines.
Should be familiar with pharmacovigilance terminology.
Excellent attention to detail.
Ability to deliver within established timelines.
Fluency in English and excellent comprehension.
Requires fluent Italian/ Spanish / German / French / Portuguese Language Translation skills
Computer literate.
COMMUNICATION SKILLS :
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross departmental communication. Ability to document and communicate problem/resolution and information/ action plans.
Desired Technical skillS :
Person should be familiar with MS Office Tools.
Safety database knowledge.
OTHER SKILLS :
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
,Keyskills :
stronginterpersonalskills msoffice dataentry drugsafety qualitycheck medicalcoding patientsafety medicalhistory technicalskills englishlanguage workeffectively communicationskills interpersonalskills qc ost isms basic tests french ortug