Drug Safety Physician /Medical Reviewer

Drug Safety Physician || B1 & B2 ||

Hi Everyone! We are currently hiring for the post of Drug Safety Physician for an Indian multinational technology company that provides IT services, consulting, and business process services. It is a leader in the Indian IT market and is one of the six leading Big Tech companies in India. Minimum of 0-6 years of Experienced Candidate is required.

please find the JD for Drug Safety Physician/Medical Reviewer role below.

JD - Drug Safety Physician/Medical Reviewer

Location: Pune / NCR/ Kolkata

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:

1. Reviewing the published reports/biomedical literature to ascertain if they contain a case report of an adverse reaction and non-individual case reports.

2. Applying regulatory and internal guidance to determine if the article meets the definition of a case report and non-individual case reports.

3. Perform relevancy assessment based on accepted industry guidelines.

4. Provide training and guidance to the scanners on inclusion criteria of case report and non-individual case reports.

5. Work closely with the SMEs to ensure physician team has necessary training and skills per industry norms.

6. 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 or DM with subject " Drug Safety Physician/Medical Reviewer " at bellow mail ID

wasimplacement1512@gmail.com

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