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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

Projektdetails

  • Einsatzort:

    The Basel Region, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 MM+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland