(SCPVIN03) Junior Drug Safety Physician (Mumbai / Pune)-Sciformix
Responsibilities
- Execute drug safety data management processes - case review, safety and medical assessment, case validation (medical coding, causality assessment, seriousness assessment, safety narrative writing)
- Write periodic safety reports and aggregate reports, including creation of case listings, population of generic parts of the report, review of literature search, label assessment and determination of exposure; review PSURs and Aggregate reports from a medical viewpoint
- Provide training and guidance to process associates on medical aspects of case processing
- Assume responsibility for quality of data processed
Skills
- Clinical research & pharmacovigilance
- Good understanding of regulatory requirements and ICH-GCP guidelines
- Technical proficiency with Microsoft Office suite of applications
- Expertise in medical review including deep understanding of applicable processes/standards
- Ability to review, analyze & synthesize medical information
- Highly focused on quality and timelines for medical deliverables
- Good oral and written communication skills
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