Global Pharmacovigilance (PV) Scientist Associate Director (AD)

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Pharmacovigilance (PV) Scientist Associate Director (AD)

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What you will do

Let’s do this. Let’s change the world. In this vital role the Global PV Scientist AD will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS. The AD level PV Scientist is able to work independently and is typically assigned to more complex programs such as those designated as Fastlane or on the prioritized agenda. Global PV Scientist lead may delegate additional tasks to the AD scientist per business need.

The Global PV Scientist Associate Director (AD) is responsible for the following:

• Independently support a complex program or multiple products or independently reviewing safety data from different indications of a given product to manage the safety profile under GSO guidance, as well as oversight and mentorship of PVSs on the product team in collaboration with the PVSL.
• Directs the planning, preparation, writing and review of safety sections of aggregate reports
• Lead 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 (in collaboration with GSO) to:
• Review and provide strategic input and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review of AEs/SAEs from clinical trials as needed
• Develop strategy and review standard design of tables, figures, and listings for safety data from clinical studies
• Lead in development of safety-related data collection forms for clinical studies
• Participate and lead for safety in study team meetings as requested or needed
• Signal detection, evaluation, and management- Lead and perform data analysis to evaluate safety signals and write up analysis results
• Develop strategy and perform documents work as required in the safety information management system
• Lead authoring of 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 and present findings where appropriate
• 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, review and analyze assessment results to support GSO
• Develop strategy and prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to regulatory filing including new drug applications
• Assist GSO in developing a strategy for safety-related regulatory activities
• Provide safety strategy and contents for filings
• Inspection Readiness
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• In addition to be the above responsibilities the following is also expected from the AD scientist as required based on the business needs:
• Lead and/or support complex programs and projects that require a higher level of expertise and serve as key driver of organizational success
• Think innovatively and strategically to identify areas of improvement and lead workstream for process improvement to increase efficiencies or consistency across Therapeutic Area or Global Safety Organization.
• Mentor or manage PV Scientist and supports PV Scientist lead in training and development of new of hires.
• PV scientist AD can serve as delegate to PVsL as needed
• PVsL may delegate additional tasks as required