Medical Reviewer : Pharmacovigilance : Life Science : MBBS/ MD : Apply

Outpace Consulting Services

1 - 6 years

8 - 15 Lacs

ahmedabad mumbai (all areas)

Posted:1 day ago| Platform:

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Skills Required

veeva medical reviewer pharmacovigilance drug safety argus cognizant wipro fda mbbs psur arisg accenture hcltech dsur clinical trials medical documentation infosys md ema case processing icsr

Work Mode

Work from Office

Job Type

Full Time

Job Description

Hi

Medical Reviewer

Key Skills :

MBBS or MD degree (mandatory)
Minimum 1 year of experience in Pharmacovigilance / Drug Safety / Medical Review
Perform medical review of adverse event cases (ICSRs) from global safety databases

Roles and Responsibilities:

Perform medical review of adverse event cases (ICSRs) from global safety databases
Assess seriousness, expectedness, causality, and medical relevance of reported events
Provide clinical judgment on safety data, product risk, and benefitrisk profile
Identify potential safety signals and support signal detection activities
Review and contribute to aggregate safety reports (PSUR/PBRER, DSUR, RMP)
Ensure compliance with global pharmacovigilance regulations (ICH, GVP, FDA, EMA)
Collaborate with Drug Safety, Quality, Regulatory Affairs, and Clinical teams
Support responses to regulatory authority queries and audits
Maintain high-quality documentation and adherence to SOPs and timelines

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