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Job Title: Medical Safety Assessment Physician
Location: Pennington, NJ
Duration: 6+ Months (Strong Possibility of Extension)
Department Title and Description
Medical Safety Assessment, Global Pharmacovigilance & Epidemiology, Research & Development
The position is likely to be from 6 months to 1-year position if the candidate performs according to expectations. It will be based in Hopewell, NJ, with occasional travel to the nearby central New Jersey sites in Princeton and Lawrenceville, NJ.
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:
• 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
• 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
MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.
Responsibility and minimum number of years
Generally, has 3 or more years previous experience as medical safety assessment physician; recent experience preparing safety aggregate reports (eg, PBRER, DSUR)
Competencies – knowledge, skills, abilities, other
• 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.
Interested candidates can send their updated resumes on email@example.com and you can also reach me at 973-967-3431.
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