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Director Patient Safety Informatics

Reference Number: 2922
Location: MA

Our client is a rapidly growing, specialty biopharmaceutical company.  They have asked us to assist them in their search for a Director Patient Safety Informatics.

Major tasks and responsibilities will include:

  • Works effectively with internal and global cross-functional teams. Collaborates with Global VP of PVRM and senior leadership teams to enhance early identification of potential safety concerns through Safety reporting, data output, data availability, and signal detection.
  • Leads global Information Management team consisting of members in the US and Japan with responsibilities including global case processing, submissions, building case series and aggregated summaries.
  • Provides regional and global support to PVRM analytics and medical review team.
  • Collaborates with PVRM leadership to identify, develop, and implement strategic short- and long- term Informatics goals.
  • Provides timely signal detection and risk management support to the PVRM Medical Directors and project teams including design and implementation of internal and external sources in adverse events reporting system databases (e.g. AERS, WHO), including interpretation and reporting on data analysis.
  • Works with PVRM Medical Directors to address drug development projects addressing specific information, analysis and interpretation challenges relating to drug safety and pharmacovigilance research.
  • Proactively identifies and supports the adjudication of safety issues.
  • Develops, identifies, maintains and facilitates the usage of software and databases to improve efficiency and accuracy in identifying and characterize potential drug safety issues.
  • Maintains knowledge/expertise of existing large databases/data sources and new/emerging methodologies and techniques, which may be suitable for identifying potential drug safety issues.
  • Collaborates with drug safety and clinical colleagues to define and prioritize informatics requirements and solution delivery. Identifies and leads engagements with external partners in the delivery of components of the clinical and drug safety informatics.
  • Promotes a positive team climate of continuous improvement and development; motivates peers to deliver competitive advantage through clear linkages between investment in people and business performance.
  • Builds knowledge and expertise of the pharma industry and informatics trends.

We seek candidates with the following qualifications:

  • Bachelor’s degree in a Life Science, Computer Science or equivalent experience with a preferred MS or PhD in Medical Informatics or related field.
  • Must have a minimum of 10 years of experience in the Pharmaceutical or related industries or a minimum of 5 years with a PhD.
  • Proven record of delivering informatics approaches, skills and tools for industrial drug projects.
  • Excellent communication skills and facilitation skills with the ability to work with others to achieve objectives.
  • Programming/scripting skills and experience (e.g. Perl & CGI, Python, UNIX shell scripting, Java, JavaScript, Excel VBA, Pipeline Pilot, etc.).
  • Database and semantic skills and experience (e.g. Oracle, MySql, RDF/Triple stores/SPARQL, etc.).
  • Experience in one or more scientific domains (e.g. Chemistry, Biology, Pharmacology, Statistics, Toxicology, Translational Science, Clinical Science, Healthcare, etc.).
  • Experience working in information delivery or tool development projects.
  • Experience working with patient safety or clinical information and analysis.
  • Scientific domain knowledge and experience in at least one of the following therapeutics areas: Oncology, Neuroscience (CNS), Respiratory & Immunology.


Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2922. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.