Medical Reviewer – Clinical Research & Drug Safety (Full-Time)
Job Summary:
Join a dynamic clinical research team as a Medical Reviewer focusing on drug safety and pharmacovigilance. The role involves comprehensive medical review and assessment of individual case safety reports (ICSRs), MedDRA coding, and evaluation of regulatory reportability. Ideal for candidates experienced in GCP, pharmacovigilance principles, and clinical drug safety review processes.
Key Responsibilities:
Perform medical review and assessment of ICSRs from clinical trials, spontaneous, and solicited reports.
Determine regulatory reportability and seriousness of adverse events across therapeutic products.
Conduct MedDRA coding, labeling assessments, and narrative reviews.
Maintain updated knowledge of assigned product portfolios and safety profiles.
Review and provide medical judgment for aggregate safety reports, signal detection reports, and risk management plans (RMP).
Participate in literature review activities relevant to safety and risk evaluation.
Prepare and review safety sections of the Company Core Data Sheet (CCDS).
Mentor junior medical reviewers and serve as a subject matter expert.
Collaborate with client therapeutic teams and functional groups for issue resolution.
Support post-marketing safety study activities and signal detection processes.
Required Skills & Qualifications:
Medical or life sciences degree (MBBS, MD, or equivalent preferred).
Strong understanding of pharmacovigilance principles, GCP, and regulatory guidelines.
Expertise in MedDRA coding and case processing of ICSRs.
Experience with safety databases (e.g., ARGUS, ArisG).
Proficiency in MS Office Suite (Word, Excel, PowerPoint).
Excellent written and spoken English communication skills; additional languages are an advantage.
Strong organizational and problem-solving skills.
Ability to guide and mentor junior team members.
Perks & Benefits:
Opportunity to work in a global clinical research environment.
Continuous learning and career development programs.
Competitive salary package (not specified).
Exposure to global pharmacovigilance practices and cutting-edge drug safety operations.
Collaborative and inclusive work culture.
Company Description:
A leading global clinical research organization specializing in drug safety, pharmacovigilance, and clinical trials. The company provides comprehensive services for the pharmaceutical and healthcare sectors, ensuring regulatory compliance and patient safety through expert medical review processes.
Work Mode:
On-site / Hybrid (Location not specified in JD)
Call to Action:
Take your clinical research career to the next level! Apply now for the Medical Reviewer role and become a key player in drug safety and pharmacovigilance.
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