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Medical Safety Assessment Physician
Ref No.: 18-00664
Location: Hopewell, New Jersey
Position Type:Contract
Start Date / End Date: 05/24/2018 to 11/23/2018
MEDICAL SAFETY ASSESSMENT PHYSICIAN
HOPEWELL, NJ


Project Description:
Medical safety lead for aggregate safety reports and strategic documents, e.g., safety aggregate reports and risk management plans.
  • Primary role: Medical safety lead for aggregate safety reports and strategic documents
  • Supports and/or Chairs Medical Surveillance Teams (MST) in overseeing and conducting safety data analysis.
  • Capable of reviewing data to perform Signal Detection/Safety surveillance; can evaluate and integrate data from multiple sources, including clinical, nonclinical and real-world, to understand and manage safety signals.
  • Plans risk strategy, risk assessment, and risk minimization for Client products in partnership with other Client functions.
  • Serves as safety consultant for product development activities.
  • Leader or key contributor to safety query responses.
  • Medical competency and scientific analytic skills.

Required Skills:
  • MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.
  • 3 or more year's previous experience as medical safety assessment physician; recent experience preparing safety aggregate reports (e.g., PBRER, DSUR).
  • Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
  • Strong written and oral scientific communication skills.
  • Strong scientific analytical reasoning skills.
  • Behavioral competencies necessary to work and lead within a complex matrix environment
  • Understanding of drug development process, with knowledge of design and execution of randomized clinical trials.
  • Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
  • Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
  • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.


This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindip@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00664
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE