Deciphera Pharmaceuticals Inc.

Job Title: Safety Physician

Job Number: 23436

Location: Waltham, MA

Job Description

Responsibilities

Key Responsibilities

  • Performs medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines
  • Accountable for seriousness, causality, and expectedness assessments; medical accuracy and completeness of ICSRs; company comment; MedDRA coding
  • Ensures that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
  • Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility
  • Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs)
  • Performs review and clarification of trial-related Adverse Events (AEs)
  • Perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative
  • Perform medical review of adverse event coding
  • Performs review of the Clinical Study Report (CSR) and patient narratives
  • Attends Kick-Off meetings, weekly team meetings, and vendor meetings, as needed or requested
  • Participates in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
  • Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments
  • Participate in development and maintenance of risk management plans and REMS
  • Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
  • Provides medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports
  • Contribute to preparation of relevant regulatory documents and responses to regulatory inquiries
  • Provides consultation for medically related questions from participating vendors, affiliates, etc.
  • Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness
  • Use in-depth knowledge of Pharmacovigilance science to provide expertise and insight to cross-functional colleagues as appropriate
  • Development/assist in creation of internal SOP and review vendor SOPs as needed.
  • Other relevant duties as assigned

Required Skills

  • Required Qualifications

    • MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent)
    • Minimum of 5 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting
    • Excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
    • Strong ability to understand and evaluate technical, scientific and medical information; exposure to clinical data collection, assessment, and analysis
    • Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented
    • Working knowledge of global drug development and pharmacovigilance guidelines and regulations
    • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
    • Excellent teamwork and collaboration; proficiency in verbal and written communication

In providing information about work experience in the application process, a candidate may include any verified work performed on a volunteer basis.  In addition, the following is for the information of applicants for employment in Massachusetts:  It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.  An employer who violates this law shall be subject to criminal penalties and civil liability.

 

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