Job Description

Associate, Global Patient Safety Operations 

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  Assist with the oversight of the Pharmacovigilance Contract Research Organization (PV CRO) performing case management and study support activities.
  
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  Assist with the management of the PV CRO to ensure compliance within the required timelines.
  
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  Provide vendors with relevant clinical study documents and updates.
  
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  Coordinate the review and filing of study plans and associated documents.
  
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  Coordinate the review and filing of PV CRO documents and monthly compliance reports.
  
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  Track and maintain well-organized department files, including listings and trackers received from CROs.
  
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  Support eTMF oversight of safety case files and relevant documents with PV and clinical CROs.
  
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  Participate and review TMF plans to capture PV and clinical CRO’s filing responsibilities.
  
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  Maintain PV CRO distribution contact lists and oversee Clinical CRO site contact lists.
  
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  Maintain meeting materials, schedule meetings, develop agendas, and track meeting minutes.
  
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  Assist with MedDRA and WHODrug coding impact analysis review.
  
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  Prepare aggregate periodic reports for departmental review and CRO distribution.
  
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  Assist with Standard Operating Procedure (SOP) cross-functional review in Quality Management System.
  
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  Perform administrative tasks to support GPS team, as needed.
  
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  Support GPS Operations team in other PV activities as appropriate to experience and expertise.
  

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  Bachelor’s degree in natural or health sciences or a minimum of 1 year of relevant industry experience in lieu.
  
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  Knowledge of Good Clinical Practice (GCP) Guidelines.
  
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  Experience in clinical trial conduct and safety reporting.
  
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  Good understanding of Software: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat, eTMF software, quality management systems (i.e., Veeva Systems).
  

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  Experience working with CROs/vendors and management of external resources is preferred.
  
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  Opportunities for successful candidates will be available to learn about safety reporting in global clinical trials and other aspects of drug safety.
  
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  Reliable, self-motivated, focused, positive attitude, proactive and solution-oriented problem solver, able to adapt to changes in priorities and tasks.
  
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  Attention to detail and excellent written and verbal communication skills.
  
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  Demonstrate the ability to manage time, prioritize tasks, and organize information effectively to meet timelines.
  
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  Excellent interpersonal skills include ability to work in cross-functional team environments and with external vendors.
  
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  Able to create and sustain strong working relationships with remote staff use video conference and instant message, as needed.
  
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  Exercise discretion regarding highly confidential internal and external communications.
  

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