Senior Manager, Global Pharmacovigilance Safety – Obesity

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🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $140.799 - $190.492 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

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Amgen

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1980

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

💰 €28.500.000.000 Post-IPO Debt im 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen ist ein weltweit führendes Unternehmen in der Biotechnologie, das sich auf die Entwicklung und Vermarktung innovativer Arzneimittel aus lebenden Zellen konzentriert. Das Unternehmen hat zum Ziel, schwere Krankheiten zu behandeln, wobei oft Krankheiten im Fokus stehen, für die es nur begrenzte therapeutische Möglichkeiten gibt. Amgen legt großen Wert auf wissenschaftliche Innovation und ist der ethischen Forschung, der Patientensicherheit und der ökologischen Nachhaltigkeit verpflichtet. Es ist aktiv in klinischen Studien engagiert und bekannt für seine Beiträge in den Bereichen Krebsbehandlung und Adipositas-Management unter anderem.

Beschreibung

• Directs the planning, preparation, writing and review of portions of aggregate reports • Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products • Supports and provides oversight to staff with regards to safety in clinical trials • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents • Review of AEs/SAEs from clinical trials as needed • Review standard design of tables, figures, and listings for safety data from clinical studies • Participate in development of safety-related data collection forms for clinical studies • Participate in study team meetings as requested or needed • Signal detection, evaluation, and management • Perform data analysis to evaluate safety signals and write up analysis results • Documents work as required in the safety information management system • Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body • Assist GSO in the development of risk management strategy and activities • Provides contents for risk management plans • Develop or update strategy and content for regional risk management plans • Assist GSOs to oversee risk minimization activities including tracking of activities as needed • Evaluate risk minimization activity • Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO • Support activities related to new drug applications and other regulatory filings • Assist GSO in developing a strategy for safety-related regulatory activities • Provide safety contents for filings • Inspection Readiness • Undertake activities delegated by the QPPV as detailed in the PV System Master File • Maintain a state of inspection readiness.

🎯 Anforderungen

• Doctorate degree and 2 years of industry pharmacovigilance experience OR Master’s degree and 4 years of industry pharmacovigilance experience OR Bachelor's degree and 6 years of industry pharmacovigilance experience OR Associate’s degree and 10 years of industry pharmacovigilance experience OR High school diploma/GED and 12 years of industry pharmacovigilance experience • Bachelor’s in life science • 2 years of managerial experience directly managing people or projects and/or mentoring experience • Clinical or medical research experience • 6 years of experience in the biotech/pharmaceutical setting

🏖️ Vorteile

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.