Drug Safety Physician
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.
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.
Company Profile
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functionsunderpinned by the worlds largest delivery networkAccenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 373,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com
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