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Senior Drug Safety Medical Writer (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
REFERENZNUMMER:
363483/11
IHRE AUFGABEN:
-Periodic Safety Update Reports, Development Safety Update Reports in collaboration with the Drug Safety Physicians, Safety Report Scientists, and the Drug Safety Management
-Participate in the planning of safety reports and development of respective specifications
-Participate in literature searches and analysis
-Participate in the assessment of worldwide cases and safety evaluation
-Cooperate with other departments involved in pharmacovigilance activities (such as Global Drug Regulatory Affairs, Clinical Science & Epidemiology, Clinical Pharmacology, Global Medical Affairs)
-Participate in reviewing and quality checking of these documents to ensure high-quality documents in compliance with regulatory requirements
-Responsible for creating working electronic folders
-Involved in writing of other regulatory reports and documents to health authorities, ethics committees and/or institutional review boards (e.g. PSMF, RMP, responses to health authority’s requests)
-Perform simple searches using Argus data in response to queries for internal use
-Give feedback regarding findings in Argus data and suggest potential Argus coding manual changes and changes to the Argus QC tool
IHRE QUALIFIKATIONEN:
-A degree in life science (e.g. BSc and/or MSc/PhD)
-English skills on native-speaker level
-Highly developed and proven medical writing skills
-Profound experience as a medical writer, preferably in the pharmaceutical industry
-Knowledge of regulatory document requirements and guidelines
-Computer literacy in Word, Excel and PowerPoint
WEITERE QUALIFIKATIONEN:
Medical writer
363483/11
IHRE AUFGABEN:
-Periodic Safety Update Reports, Development Safety Update Reports in collaboration with the Drug Safety Physicians, Safety Report Scientists, and the Drug Safety Management
-Participate in the planning of safety reports and development of respective specifications
-Participate in literature searches and analysis
-Participate in the assessment of worldwide cases and safety evaluation
-Cooperate with other departments involved in pharmacovigilance activities (such as Global Drug Regulatory Affairs, Clinical Science & Epidemiology, Clinical Pharmacology, Global Medical Affairs)
-Participate in reviewing and quality checking of these documents to ensure high-quality documents in compliance with regulatory requirements
-Responsible for creating working electronic folders
-Involved in writing of other regulatory reports and documents to health authorities, ethics committees and/or institutional review boards (e.g. PSMF, RMP, responses to health authority’s requests)
-Perform simple searches using Argus data in response to queries for internal use
-Give feedback regarding findings in Argus data and suggest potential Argus coding manual changes and changes to the Argus QC tool
IHRE QUALIFIKATIONEN:
-A degree in life science (e.g. BSc and/or MSc/PhD)
-English skills on native-speaker level
-Highly developed and proven medical writing skills
-Profound experience as a medical writer, preferably in the pharmaceutical industry
-Knowledge of regulatory document requirements and guidelines
-Computer literacy in Word, Excel and PowerPoint
WEITERE QUALIFIKATIONEN:
Medical writer
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges