Associate Director, Global Drug Safety & Pharmacovigilance Data Management

A New Jersey-based biotech company is actively seeking a new Associate Director of Global Drug Safety & Pharmacovigilance Data Management to join its growing team.

About the Opportunity:

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  Schedule: Full-time

  
  


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  Hours: Standard business

  
  


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  Setting: Hybrid (at least 2 days a week onsite)

  
  

Responsibilities:

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  Triaging and reviewing Argus configuration requests

  
  


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  Conducting strategic UAT, including test planning and execution

  
  


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  Ensuring compliance with ICH E2B(R2) and (R3) conventions

  
  


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  Managing communication with stakeholders and escalating issues

  
  


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  Participating in safety application projects as a business SME

  
  


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  Performing other duties, as needed

  
  

Qualifications:

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  Experience in Oracle Argus Safety system configuration and administration

  
  


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  Expertise in ICH E2B(R2) and ICH E2B(R3) conventions

  
  


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  Experience with safety case processing and ICSR reporting

  
  


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  Knowledge of PV regulations and guidance

  
  


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  Ability to produce audit-ready UAT documentation

  
  


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  Stakeholder management skills

  
  


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  Strong communication skills

  
  


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  Ability to translate business needs into system requirements

  
  


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  Attention to detail

  
  

Desired Skills:

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  Advanced Degree in a related field

  
  


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  Additional experience in Argus Safety

  
  


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  Applicable certifications

  
  


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  Proficiency in Regulatory compliance