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Drug Safety Physician
3 months ago
Role - Drug Safety Physician
Designation – Sr. Executive
Location - Wipro Pune, Hinjewadi Phase 2.
Education Qualification: Only MBBS, MD Pharmacology preferred.
Experience: 0-3Yrs. (Freshers-only if clinical research experience)
Preferably Immediate joiners.
Role & Responsibility
1. Reviewing the published reports/biomedical literature to ascertain if they contain a case report of an adverse reaction and Non- individual case reports.
2. Applying regulatory and internal guidance to determine if the article meets the definition of a case report and Non- individual case reports.
3. Perform relevancy assessment based on accepted industry guidelines.
4. Provide training and guidance to the scanners on inclusion criteria of case report and Non- individual case reports.
5. Work closely with the SMEs to ensure physician team has necessary training and skills per industry norms.
6. Perform additional tasks/responsibilities as assigned delegated by the team lead/manager.
Technical/Functional Competency
1) Sound Knowledge of Human Anatomy & Physiology
2) MedDRA Coding & subsuming of adverse drug reaction/AE terms
3) Seriousness determination
4) Familiarity with pharmacological concepts
5) Command on verbal and written communication skills
6)Team Player