Medical reviewer @ Golden Opportunities

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Medical reviewer

Golden Opportunities
1 - 7 Years
Chennai
5 years ago
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Job Description

Medical review of the ICSRs (clinical spontaneous Drug surveillance literature and spontaneous) adhering to SOP designed by client.
Keeping track of updates of the drug and cascade to drug safety pharmacovigilance into clinical trials.
Communication and discussion with the client to assure case coding with adherence to coding Guidelines. Retrospective review of the line listing ICSRs within time-lines..
Training on guidelines submission and labeling aspect of the case.
Safety package drafting and mailing it to client within timelines to assure in time 7-15 day Submissions.
Solving of queries regarding Med-Dra coding labeling and narrative of the ICSRs.
Involved in review in eCRF for protocol defined criteria like event of special interest endpoints and Sentinel events etc.
Performed review of eCRF for cancer/neoplasm events for assessment of protocol defined criteria and report it in timelines
candidate should have at least 1+ years of experience in Pharmacovigilance.
Excellent communication is required.

Work Timings: Candidates should be flexible working in a 24*7 environment

Employement Category:

Employement Type: Full time
Industry: Bio Technology & Life Sciences
Functional Area: Pharmaceutical
Role Category: Clinical Research Associate
Role/Responsibilies: Medical reviewer

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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Keyskills: Medical reviewer Pharmacovigilance Drug safety ICSR Mbbs MCI

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Preferred City (* max. 2 w/comma)

Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

I agree with website service terms and conditions

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Medical reviewer @ Golden Opportunities

Home > Clinical Research Associate