Get Clinical Research JobsGet Clinical Research Jobs

Pharmacovigilance Scientist


  • Beacon Hill Staffing Group - Pharma
  • 01/20/19
  • Boston, MA
  • 02114
  • 100.00 / Hourly
  • Contractor
Duties: Signal Detection and Medical Surveillance Activities 40 % of Time
Independently evaluates data, identifies opportunities and risks, weighs alternatives and presents analyses to Medical Director for review.
Organize planned and ad hoc safety review activities - Obtain data for signal assessment (e.g., Oracle AERS, FDA AERS data, literature search); generate/request listings, identify cases, prepare initial assessment for review and finalization by Medical Director, follow-up on meeting outcome (as needed), ensure the appropriate maintenance of relevant documentation.
Quarterly AE Review of Clinical Trials - Perform first iteration of listings review, discuss issues with Medical Director Lot Review - Prepare listing and table for Medical Director review and summary Literature Surveillance - Perform review of literature with appropriate documentation; identify case reports as well as new safety information and alert Medical Directors, as appropriate
Clinical Trial Support 25 % of Time
Oversee and perform case processing activities working with CTSA to ensure consistency, as needed Investigator Brochure (IB): Contribute to creation, review and updates of IB Aggregate Reports for investigational products such as DSURs, ASRs, IND Annual - collect, collate, format and draft PVRM data contribution IND Safety reports - analysis of similar events - Collect, collate, format and draft data contribution and perform first review Database Lock - Perform reconciliation and signoff See attached JD for more information.

Skills:
Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs departments required.
Minimum of 2-3 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS and/or Common Technical Document, or white paper) and/or experience in Medical Surveillance and Risk Management.
Proven understanding of clinical disease state and implications of treatment.
At ease with data and statistics.
Proven ability to communicate effectively (verbal, presentation at group meetings, etc).
Proven experience with project management (formal or informal).
Strategic thinking, organizational leadership, results-oriented performance, team player.
Knowledge of ICH, US / EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines) and Risk Management.
Excellent interpersonal skills, including ability to work effectively, cross culturally and cross functionally.
Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred.


Browse other Clinical Research Jobs in Massachusetts

  1. Hematology Attending

    Boston, MA
    The Division of Hematology Oncology in the Department of Medicine at Tufts Medical Center and Tufts University School of Medicine...
  2. Clinical Research Project Manager

    Boston, MA
    The New England Centenarian Study (NECS) based on Boston University's medical campus is seeking a full-time research project manag...
  3. Clinical Site Manager (CRA)- Massachusetts...

    Boston, MA
    PAREXEL has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and sit...
  4. 105414 - Clinical Research Scientist

    Lexington, MA
    Job Description Minimum Requirements: · RN, MS, PhD or PharmD, with clinical research experience and a strong knowledge of drug...
  5. Senior Clinical Research Associate ONCOLOGY REMOTE

    Boston, MA
    Job Description ONCOLOGY Senior Clinical Research Associate REMOTE Provident Research is looking for individuals to be responsibl...
  6. Clinical Data Coordinator

    Boston, MA
    Job Description We have an exciting opportunity available in downtown Boston, MA for a recent graduate who is looking to step int...
  7. Research Scientist

    Boston, MA
    Job Description OBJECTIVES: Intensity Therapeutics (www.IntensityTherapeutics.com) is a clinical stage biotechnology company pion...
  8. Hematology Attending

    Boston, MA
    The Division of Hematology Oncology in the Department of Medicine at Tufts Medical Center and Tufts University School of Medicine...
  9. Clinical Research Director

    Waltham, MA
    The Clinical Research Director (CRD), Rare Blood Disorders Therapeutic Area, is responsible for contributing to the creation and e...
  10. Sr. Director, Clinical Research

    Boston, MA
    Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the tran...