Biotech/Pharmaceutical

Clinical Safety Physician Consultant – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: The Clinical Safety Consultant is an experienced drug safety physician (MD) who will provide ongoing medical evaluation/review of cases (ICSR) and assessment of the risk-benefit profile (including risk tracking) for assigned oncologic molecules. Responsibilities include managing all safety issues and regulatory requirement/submission for one or more molecules in development and serve as an expert resource for the rest of the team regarding safety issues.

Responsibilities:

  • Provide Medical Review that is heavily integrated into the ICSR workflow including verifying accuracy of previously entered assessments, creating a Company comment, and an analysis of Similar Events
  • Execute the Signal management process including detection, evaluation, and communication of additional risk minimization measures
  • Present patient data in the context of the Clinical Trial and make recommendations to the Executive Safety Advisory Committee
  • Leads Investigator Brochure development for safety sections including Reference Safety Information
  • Interact with Drug Safety Operations for training opportunities identified, ensuring compliance within workflow, continuous quality improvement (CQI), and other areas as needed
  • Participate in cross functional monitoring of the study data with Medical Monitors, Biostatistics, and the VP, Clinical Safety & Risk Management
  • Lead for one or more molecules in development and support clinical study teams with safety issues, IB, DSUR, protocol, ICF, CSR, case reviews etc.
  • Contribute to clinical trial protocols, IND/NDA submissions, and Risk Management Plans
  • Assist in the preparation of aggregate reports and other safety-related documents or sections that may include: DSURs, 6-month line listings, internal safety assessment reports
  • Develop materials and conduct training sessions when appropriate to a variety of audiences
  • Assign priority within a clinical development environment at all phases of multiple programs

Qualifications:

  • MD or equivalent medical training
  • 2+ years of clinical experience, post-residency (internal medicine, HemOnc, immunology preferred) and 3+ years of experience in Drug Safety/Pharmacovigilance
  • Expert knowledge of FDA CFR, ICH, and clinical development programs is required
  • Medical writing experience required
  • Working knowledge of EMA GVP and CIOMS
  • Drug safety surveillance experience in oncology/hematology preferred
  • Experience providing Drug Safety support for clinical development programs in a cross-functional collaborative manner
  • Knowledge and ability to apply industry best practices to interpret related regulatory guidance and problem solve towards a compliance approach
  • Working knowledge of MedDRA coding and its appropriate use in data mining
  • Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives
  • Ability to work efficiently and effectively with minimal supervision
  • Ability to mentor and coach staff
  • Excellent collaboration and communication skills are required with the ability to present information to a wide range of audiences

Tagged as: Clinical Safety Physician Consultant - Remote