Team Lead - CDM/PV

Qualification:

Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse

Responsibility:

Business/ Customer:

• Minimal Customer interaction under guidance.

• Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists).

• 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.

• • Import uncoded terms in database and export coded medical terms from coding platform.

• • Query Management.

• • Create “New Term Request” and prioritize.

• • Perform Dictionary upversioning activity as and when required.

CDM:

• Limited to study conduct activities.

• Data review and Query management is done with assistance.

• Limited email conversations with Client.

• Every activity requires Peer QC by supervisor or allocated seniors.

• NO INVOLVEMENT in Set Up and Migration activities.

• 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.

• Adhere to quality requirements, achieve targets/volumes in given TAT(Turn around time).

• 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

• Pharmacovigilance&Safety Ops

• PV Case Processing

Employee Status : Full Time Employee