Job Description :

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

PROCESSES : 

Responsibilities/ Authorities :

Reviews and verifies appropriate selection of adverse events from source documents, appropriate MedDRA 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:

oNo special physical demands. 

oMajor part of work done in office environment. 

oHigh degree of accuracy and attention to detail. 

oPrevious computer experience. 

oSkill in Medical Writing

oAbility to read and interpret AE cases and medical literature, draw conclusions, and draft aggregated reports. 

oKnowledge of Medical Safety Standards.