Drug Safety Physician/Medical Reviewer
13 hours ago
Drug Safety Physician/Medical Reviewer role below.
JD - Drug Safety Physician/Medical Reviewer
Location: Pune
Work Mode: Temporarily WFH (6 Months)-This is only for B1
For B2- WFO & Location- Pune/Kolkata/NCR
Shift: General shift
Qualification: MBBS/MD (If Foreign graduate, FMGE is must)
B1 - Experience: 0-3 years
Budget: 12-15 LPA
B2 - Experience: 3-6 years
Budget: 16-24 LPA
Please look for Immediate Joiners only
Roles and Responsibilities:
Reviewing the published reports/biomedical literature to ascertain if they contain a case report of an adverse reaction and non-individual case reports.
Applying regulatory and internal guidance to determine if the article meets the definition of a case report and non-individual case reports.
Perform relevancy assessment based on accepted industry guidelines.
Provide training and guidance to the scanners on inclusion criteria of case report and non-individual case reports.
Work closely with the SMEs to ensure physician team has necessary training and skills per industry norms.
Perform additional tasks/responsibilities as assigned delegated by the team lead/manager
Technical/Functional Competency:
1) Sound knowledge of regulatory guidelines related to PV domain
2) Narrative Writing
3) MedDRA Coding
4) Familiarity with pharmacological concepts
5) Command on verbal and written communication skills
6) Team Player
Screening Questions:
What is PV.
What is signal detection in PV.
Name some causality assessment skills used in PV.
What are the sections which are present on the drug label.
How to assess the seriousness of adverse event.
What is individual case safety report (ICSR)
What is medication error
What is off label use of drug
What is drug abuse and misuse
Name some antibiotics
During COVID, what were the drugs that were used for off label treatment of COVID
Side effects of Steroids
What do you mean by regulatory authorities for pharmacovigilance in India
What is aggregate safety reporting
How will you decide given event is serious, based on what criteria
What is DME list
Difference between IME & DME list
Off label, misuse and abuse of drug - define
And questions related to Drugs and side-effects
Application of Drug in Clinical aspect, PV, Pharmacology
Eligible candidates share CV with Subject line "Drug Safety Physician/Medical Reviewer" at below mail ID
MedicalReviewer #DrugSafety #Wipro #Acceture #WNS-
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