Beschreibung
Wir, die Accessio IMS, suchen ab dem 03.05.2021 für unseren Kunden einen Freelancer CMO Consultant (m/f/d) für ca. 12 Monate mit Option auf Verlängerung am Standort Raum Darmstadt.Main responsibilities:
• Signal Detection & Management: Undertake signal detection activities on safety data sets from various sources, such as spontaneous adverse event listings, clinical trial datasets, reports or datasets from observational studies- and present summaries of the data in a meaningful way. Analyze safety signals, author signal evaluation reports and present results to governance committees as required. Literature review: review publications from the scientific/medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (eg PSURs, Signal Evaluation reports).
• Periodic safety reports: contribute individual safety relevant key sections for the preparation of aggregate safety reports (Periodic Safety Update Reports, Development Safety Update Reports etc.) per projected timelines and in collaboration with cross functions.
• Benefit-Risk Management: Contribute to risk management activities including authoring of safety related justification documents in support of company/development core safety information and safety relevant label updates, risk communications, Risk Management Plans.
• Submissions: Assist in responding to Health Authority requests. Contribute safety relevant content to HA briefing books, integrated summary of safety analyses, CTD modules, Renewals and safety variations.
• Clinical Trials: Conducting analyses for aggregate safety monitoring during study conduct, contribute individual safety relevant input for the preparation of submission dossiers, Investigator’s brochure and Informed consent form and other trial related documents.
Education:
• Minimum of Masters (or international equivalent) in science, medicine/health sciences, or pharmaceutical science
Experience:
• At least 5 years progressive experience within the Pharmaceutical/Biotech industry or Health Authority and advanced experience in Pharmacovigilance
• Experience in signal management – specifically signal detection in varying data sources across the product life cycle, as well as problem solving in the methods and approaches to answering complex regulatory queries.
Competencies:
• Advanced understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines and standards
• Understanding of ICH GCP and drug development
• Computer proficiency in basic database entry and graphics presentations (e.g.spotfire)
• Excellent written and verbal communication skills in English, with the ability to evaluate, interpret and synthesize scientific data
• Self-motivated, able to prioritize and plan effectively
• Ability to work independently and as a team player, working in a cross functional environment
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