Medical Reviewer

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Skills you'll use

What you'll do

• Analyzes, reviews, and interprets safety data, both non-clinical and clinical.
• Performs medical review of ICSRs, and other drug safety information from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate and literature reports.
• Provides technical and medical expertise in medical assessment of causality of Individual Case Safety Report (ICSR) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes.
• Contributes to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements.
• Contributes to the development of Standard Operating Procedures, Working Instructions and other guidance documents.
• Contributes to safety and pharmacovigilance training programs.
• Provides safety training at investigator meetings.
• Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
• Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
• Training and mentoring of Pharmacovigilance Physicians and Specialists.

Who can apply

• 1-3 years’ experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable.
• Medical Degree (MBBS or higher) from recognized medical school.

Perks & benefits

About Sitero

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