Drug Saftey Specialist in Lexington, MA at Apex Life Sciences

Date Posted: 5/14/2018

Job Snapshot

  • Employee Type:
  • Location:
    Lexington, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
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Job Description

Drug Saftey Specialist

The Drug Safety Assessment Specialist supports the Product Characterization and Risk Assessment program within Toxicology Department at Shire. As a contractor, this position will closely work with the Head of Product Characterization and Risk Assessment to build and maintain important database to support various types of safety assessment to support research, development, commercialization and life cycle management of pharmaceuticals. 
• Organize, categorize and archive all existing and new human health, environmental and occupational safety assessment documents 
• Generate and maintain the human health, environmental and occupational safety assessment tracking database to ensure the consistency, transparency and efficiency of the PCARA process 
• Review existing safety assessment documents to extract critical chemical toxicology information 
• Based on the existing toxicological risk assessment reports, generate the chemical toxicological profile and summary database to support prospective chemical safety assessment 
• Under supervision and instruction, maintain and update the chemical point of departure and human safety threshold database 
• Build the Shire pharmaceuticals posology database to assist safety assessment 
• Support the environmental fate and effects testing and risk assessment database management 
• Assumes other drug safety assessment responsibilities as needed 
• Minimum of Bachelor of Science degree in the field of toxicology, pharmacology, biology or related. Some work experience in relevant field is plus. 
• The scope of the responsibilities is to support Shire business. 
• Experience and capability in using database management systems and programs (e.g., Microsoft Access, Excel programming) is highly preferred. 
• Strong skills in project management, risk management, problem-solving and communication effectiveness. 
• Must be capable of effectively interacting with internal and external customers. 
• High capability to deal with complexity of projects and identify solutions to support business. 
• Be able to work independently as well as with a teamwork spirit. 
• Demonstrated ability to work effectively for prompt results delivery in a fast-paced environment. 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.