Job Details

  • Title: Regulatory & Medical Affairs - Physician
  • Code: RCI-31993-1
  • Location: Lawrenceville New Jersey (NJ) 08648
  • Posted Date: 07/02/2020
  • Duration: 12 Months
Talk to our Recruiter

  Job Description

Department Title and Description

  • Medical Safety Assessment, Global Pharmacovigilance & Epidemiology, Research & Development

Purpose/Objective of the job:
  • Medical safety lead for aggregate safety reports and strategic documents, eg, safety aggregate reports and risk management plans

Key Responsibilities and Major Duties:
  • Leader or key contributor to safety query responses.
  • Plans risk strategy, risk assessment, and risk minimization for Client products in partnership with other Client functions
  • Supports and/or Chairs Medical Surveillance Teams (MST) in overseeing and conducting safety data analysis
  • Primary role: Medical safety lead for aggregate safety reports and strategic documents
  • 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
  • Serves as safety consultant for product development activities.
  • Medical competency and scientific analytic skills

Key Stakeholders/Contacts
  • Internal Matrix: Safety Scientist, Scientific Writer, Epidemiologist, Clinical Safety Program Lead, Medical Review Safety Physician, Therapeutic Area Head, Administrative Assistants
  • External Matrix: Medical Team Leads, Development team leads, Medical Monitors, Global and Regional Regulatory Leads, Biostatistics Lead, Operation Lead, Pre-Clinical Safety Lead (Drug Safety Evaluation), Labeling Lead Clinical Leads, Project Management as appropriate to stage of development, business partner(s) as appropriate

Degree/Certification/Licensure

  • MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.

Experience – Responsibility and minimum number of years
  • Generally, has 3 or more years previous experience as medical safety assessment physician; recent experience in early drug development (pre-approval)

Competencies – knowledge, skills, abilities, other
  • Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
  • Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
  • Strong scientific analytical reasoning skills
  • Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
  • Strong written and oral scientific communication skills
  • Behavioral competencies necessary to work and lead within a complex matrix environment
  • 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
  • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.