Qualification:
Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse
Responsibility:
Business/ Customer:
• * Minimal Customer interaction under guidance.
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• Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists).
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• For PV/Complaints Management Individuals in this role perform data entry of data received from Source documents into the respective Clinical/Safety database While peroforming this activity the associate is responsible for meeting turnaround times and accuracy.
• CODING:
(same as SPE)
• * Perform coding activities on the assigned project with timelines and efficiency.
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• • Import uncoded terms in database and export coded medical terms from coding platform.
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• • Query Management.
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• • Create “New Term Request” and prioritize.
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• • Perform Dictionary upversioning activity as and when required.
• CDM:
• * Limited to study conduct activities.
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• Data review and Query management is done with assistance.
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• Limited email conversations with Client.
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• Every activity requires Peer QC by supervisor or allocated seniors.
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• NO INVOLVEMENT in Set Up and Migration activities.
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• Limited involvement of data pad locking activities during timelines of DataBase locks.
• Project / Process:
• * Handles First level processing of assigned transactions, Complex problems (procedures/processes) are referred to Supervisor/Line Manager.
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• Adhere to quality requirements, achieve targets/volumes in given TAT(Turn around time).
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• Adhere to the mandatory industry regulation and compliance requirements for the given process.
• Knowledge Management:
• * Understand various document templates and standards(Such as SOP's) to interpret the documents related terminologies.
• People/Team Management:
• * Adhere to org hygiene and compliance needs in terms of Time sheet submission, Assimilation Attendance.
• Good To Have Skills
• * PharmacovigilanceSafety Ops
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• PV Case Processing
• Employee Status : Full Time Employee
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