Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labelling, causality and provide a medical assessment comment as needed for ICSR. 
o Reviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency between source documents and narrative summary. 
o Actively follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness. Start an Ad-hoc follow-up whenever required. 
o Constantly update domain and operations skills as per the changing Regulatory requirements by reading the updated version of SOP. 
o Route the Case to Distribution and ensure the case is locked. 
o Provide feedback for the Case creation and data entry production leads about the quality of data entry in serious cases. 
o Actively involved in case discussion with client and provide the valuable inputs to the team. 
o Offline peer review of agreed sample of Cases for assessment of quality of narrative, E2B sender’s comment and medical query completeness 
o To participate in audits or inspections. 
o Training and mentoring of new associates. 
o Authoring of process documents
o Drug safety related activities.

Desired Profile: -
• Adaptable and flexible 
• Quick learner and a team player 
• Minimum of medical degree (MBBS). Medical degree with higher speciality preferred. 
• Min. 2 to 5 years of experience (in ICSR medical review).
• In-depth knowledge of medical terminology 
• Good Communication Skills, medical writing skills and Analytical Ability 
• Strong English Language proficiency

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41599-Pharmacovigilance-Medical Review (CL 8 & 9)

OVERVIEW

Location: Bangalore

Job Title : 41599-Pharmacovigilance-Medical Review (CL 8 & 9)

Experience : 2.0 yrs - 5.0 yrs

CTC : INR 13.00 lacs - 30.00 lacs

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41599-Pharmacovigilance-Medical Review (CL 8 & 9)
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Roles and Responsibilities 
o Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labelling, causality and provide a medical assessment comment as needed for ICSR. 
o Reviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency between source documents and narrative summary. 
o Actively follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness. Start an Ad-hoc follow-up whenever required. 
o Constantly update domain and operations skills as per the changing Regulatory requirements by reading the updated version of SOP. 
o Route the Case to Distribution and ensure the case is locked. 
o Provide feedback for the Case creation and data entry production leads about the quality of data entry in serious cases. 
o Actively involved in case discussion with client and provide the valuable inputs to the team. 
o Offline peer review of agreed sample of Cases for assessment of quality of narrative, E2B sender’s comment and medical query completeness 
o To participate in audits or inspections. 
o Training and mentoring of new associates. 
o Authoring of process documents
o Drug safety related activities.

Desired Profile: -
• Adaptable and flexible 
• Quick learner and a team player 
• Minimum of medical degree (MBBS). Medical degree with higher speciality preferred. 
• Min. 2 to 5 years of experience (in ICSR medical review).
• In-depth knowledge of medical terminology 
• Good Communication Skills, medical writing skills and Analytical Ability 
• Strong English Language proficiency

Other Details

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