Senior Manager, Global Patient Safety Operations

Senior Manager, Global Patient Safety Operations

The Opportunity:

This position will be responsible for managing, developing, and overseeing Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned clinical programs.

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  Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.
  
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  Represent Global Patient Safety in different cross-functional team meetings. Collaborate with other functional groups to achieve clinical program goals.
  
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  Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.
  
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  Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.
  
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  Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.
  
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  Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs.
  
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  Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.
  
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  Support the execution and maintenance Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners.
  
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  Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.
  
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  Support Global Patient Safety team in other PV activities appropriate to experience and expertise.
  
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  May oversee or be responsible for one or more junior team member(s).
  

Required Skills, Experience and Education:

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  Bachelor’s degree in a healthcare field.
  
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  Minimum of 5 years of relevant experience in pharmacovigilance operational activities.
  
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  Hands-on experience working with CROs/vendors and management of external resources.
  
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  Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials.
  
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  Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.
  

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  Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives.
  
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  Ability to persuade others in sensitive/complex situations while maintaining relationships
  
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  An innovative team player with the capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.
  
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  Excellent interpersonal skills, including the ability to work in cross-functional team environments and with external vendors.
  
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  Exercise discretion regarding highly confidential internal and external communications.
  

Preferred Skills:

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  Master’s Degree or higher in a healthcare field.
  
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  7+ years of relevant experience in pharmacovigilance operational activities.
  
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  Experience working with investigator-sponsored trials, extended use programs, and business partnerships.