Perform medical review (including verifying the coding & labeling, reviewing seriousness, narratives, causality statement, medical aspect of followup request), validate followup request and perform medical assessment of the case as applicable.
Responsible for maintaining Medical cohesiveness of a case.
Maintaining the data as per the client specific SOPs and guidelines.
Project/ Process:
Perform Medical Review of assigned cases.
Adhere to the mandatory regulation and client guidelines/ SOPs and compliance requirements for the given process.
Adhere to quality requirements, achieve targets/volumes in given TAT(Turn around time).
Understand various SOP document and templates to interpret the documents & related terminologiesShould be well versed and updated with the pharmacovigilance, GCP and regulatory guidelines Moved from Knowledge Management.
People/Team Management:
Adhere to org hygiene and compliance needs in terms of:
a Personal Utilization & Time sheet submission.
b Personal and new hire Assimilation.
c Attendance.
d Team Initiatives.
Collate team performance metrics.
Manage break schedule/transport logistics for the team in the absence of his/her supervisor.
Must Have Skills
Pharmacovigilance&Safety Ops
PV Medical Review
Experience
1 - 5 Years
Salary
+ Lac To 13 Lac P.A.
Industry
Health Care / Pharmaceuticals / Medical
Qualification
Higher Secondary
Key Skills
Good Communication skill MMBS Medical Reviewer Medical Review Medical Executive