OPENING : DRUG SAFETY PHYSICIAN : CHENNAI : "D"

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Drug Safety Physician

Job Location:Chennai

Job Number:J1715

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Job DescriptionQualifications

Schedule: Full-time

OVERALL PURPOSE OF JOB 

Reviewing medical literature, safety data, draw conclusions from safety reports, clinical reports, proficiency in medical report writing and safety standards. Clinical Review of all cases - serious and non-serious safety reports
Responsibilities/Authorities :

? Reviews and verifies appropriate selection of adverse events from source documents, appropriate code for each adverse event and accuracy of label assessments for each adverse event. Adjust to changing regulatory environment.
? Provides a medical evaluation comment for all serious spontaneous, unlisted adverse events and serious related events from studies and solicited adverse events
? Provides assessment(s) for study cases and solicited reports.
? Reviews the source document to assure relevant information pertaining to the case is appropriately entered
Requirements:
o No special physical demands.
o Major part of work done in office environment.
o High degree of accuracy and attention to detail.
o Previous computer experience.
o Skill in Medical Writing
o Ability to read and interpret AE cases and medical literature, draw conclusions, and draft aggregated reports.
o Knowledge of Medical Safety Standards.