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Drug Safety Physician (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
REFERENZNUMMER:
373823/11
IHRE AUFGABEN:
-As a Drug Safety Physician you work in a team-oriented global environment and will be responsible for the overall medical evaluation of adverse event information, conduct routine Pharmacovigilance, initiate safety-related product labeling changes based on risk assessment, and prepare safety evaluations for regulatory reports
-Contribute to triage for their respective cases
-Contribute in the triage and assessment of worldwide cases, as necessary
-Provide good quality medical review of adverse events reports for the responsible products
and of adverse events reports for other products as needed -Checking for correctness of adverse event/case labeling and causal relationship, association of diagnosis and signs/symptoms and providing medical comments, as appropriate
-Clarify complex medical information and provide consultation on coding issues for DS Coding Specialists and DS Scientists
-Perform follow-up as applicable, contact the reporter as appropriate for clarification,
Identification of missing information/inconsistencies and completion of Data Clarification Forms via SmartTrack -Perform ‘analysis of similar events’ for suspected unexpected serious adverse reaction cases and review periodic serious adverse reaction cases listings
-Review medical literature for the responsible product
IHRE QUALIFIKATIONEN:
-Preferably international experience in the Drug Safety environment of pharmaceutical industry, and in collecting, analyzing, assessing and reporting adverse events associated with investigational and marketed products
-Doctor of Medicine degree with license
-Knowledge of international safety regulations
-Strong verbal and written English communication skills
WEITERE QUALIFIKATIONEN:
Drug safety manager
373823/11
IHRE AUFGABEN:
-As a Drug Safety Physician you work in a team-oriented global environment and will be responsible for the overall medical evaluation of adverse event information, conduct routine Pharmacovigilance, initiate safety-related product labeling changes based on risk assessment, and prepare safety evaluations for regulatory reports
-Contribute to triage for their respective cases
-Contribute in the triage and assessment of worldwide cases, as necessary
-Provide good quality medical review of adverse events reports for the responsible products
and of adverse events reports for other products as needed -Checking for correctness of adverse event/case labeling and causal relationship, association of diagnosis and signs/symptoms and providing medical comments, as appropriate
-Clarify complex medical information and provide consultation on coding issues for DS Coding Specialists and DS Scientists
-Perform follow-up as applicable, contact the reporter as appropriate for clarification,
Identification of missing information/inconsistencies and completion of Data Clarification Forms via SmartTrack -Perform ‘analysis of similar events’ for suspected unexpected serious adverse reaction cases and review periodic serious adverse reaction cases listings
-Review medical literature for the responsible product
IHRE QUALIFIKATIONEN:
-Preferably international experience in the Drug Safety environment of pharmaceutical industry, and in collecting, analyzing, assessing and reporting adverse events associated with investigational and marketed products
-Doctor of Medicine degree with license
-Knowledge of international safety regulations
-Strong verbal and written English communication skills
WEITERE QUALIFIKATIONEN:
Drug safety manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges