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Job Location: Pune
Job Detail:
- Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse
Responsibilities: Business/Customer:
- Minimal customer interaction under guidance.
- Understands domain process/sub-process, functions, and terminologies (such as SOP, QC checklists).
For PV/Complaints Management:
- Perform data entry of data received from source documents into the respective Clinical/Safety database.
- Responsible for meeting turnaround times and accuracy during data entry.
Coding:
- Perform coding activities on the assigned project with timelines and efficiency.
- Import uncoded terms into the database and export coded medical terms from the coding platform.
- Manage queries.
- Create New Term Request and prioritize.
- Perform dictionary upversioning activity as required.
CDM:
- Limited to study conduct activities.
- Data review and query management done with assistance.
- Limited email conversations with clients.
- Every activity requires peer QC by a supervisor or allocated seniors.
- No involvement in set up and migration activities.
- Limited involvement in data pad locking activities during database locks.
Project/Process:
- Handle first-level processing of assigned transactions. Complex problems are referred to the supervisor/line manager.
- Adhere to quality requirements and achieve targets/volumes within given TAT (Turnaround Time).
- Comply with mandatory industry regulations and compliance requirements for the given process.
Knowledge Management:
- Understand various document templates and standards (such as SOPs) to interpret the documents and related terminologies.
People/Team Management:
- Adhere to organizational hygiene and compliance needs in terms of timesheet submission, assimilation, and attendance.
Good to Have Skills:
- Pharmacovigilance Safety Operations
- PV Case Processing
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