Clinical Operations

  • location: Lexington, MA
  • type: Contract
  • salary: $74.97 - $88.19 per hour

job description

Clinical Operations

Safety Analytics Scientist

True Title: Risk Management Lead

Job Summary

  • The Global Drug Safety Risk (GDS) Management Lead is the drug safety expert for assigned products; maintains current knowledge of assigned product portfolio and safety profiles for products.
  • He/she is responsible for safety risk assessment, management, minimization and communication for assigned development and marketed products.
  • He/she is also provides input into and review of aggregate reports and safety documents, including labeling changes.
Job Responsibilities

  • Responsible for the implementation of benefit-risk management for company products. Development of REMS, DRMP's & RMP's, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies.
  • Actively participates in Benefit- Risk Committees and other safety committees as needed. Effectively manages the Benefit/Risk process.
  • Prepares and assists in the management of Risk Management project timelines. Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off. Ensure all regulatory commitments in RMP's are followed & tracked.
  • Represent Risk Management on cross functional teams and Interface with other company functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
  • Communicates effectively on product risks to Risk Management Team Lead.
  • Provide advice and liaises with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment.
  • Critically review & provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission & ad hoc reports. Ensures that the safety risks with Shire projects/products are identified promptly
  • Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed
  • Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates
  • Participate in other activities, teams and committees as assigned
Education & Qualifications

  • MD, PhD, Pharm D, or Master's degree in a science or healthcare related discipline with specialty training in functional area and at least 2 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
  • At least 2 years of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies or commensurate experience.
  • Previous experience in bioscience preferred
  • Ability to read and analyze scientific and medical literature
  • Ability to work with interdisciplinary, highly matrixed team
  • Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
  • Analytical and problem solving skills
  • Oral and written communication and interpersonal skills
  • Planning and Organizing
  • Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines
  • Ability to establish and maintain professional communication both internally and externally with all stakeholders

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

get jobs in your inbox.

sign up

related jobs

    Clinical Operations

  • location: Cambridge, MA
  • job type: Contract
  • salary: $74 - $86.53 per hour
  • date posted: 4/26/2018

    Clinical Operations

  • location: Cambridge, MA
  • job type: Contract
  • salary: $55.07 - $64.79 per hour
  • date posted: 6/7/2018

    Clinical Operations

  • location: Andover, MA
  • job type: Contract
  • salary: $56.29 - $66.22 per hour
  • date posted: 5/22/2018