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Drug Safety Specialist


The Hird


Location

Pune | India


Job description

Role – Drug Safety Physician. Designation – Sr. Executive. Location – Pune. Qualification – MBBS/MD (Pharmacology). Experience – 1 to 7 Years Mode - Work from Office. (Pune) Notice Period – Immediate joiners preferred. CTC- Upto 24 LPA

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 the 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) Regulatory guidelines of pharmacovigilance of different countries 6) Command on verbal and written communication skills 7)Team Player


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