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Drug Safety MD needed for Medical Director role with mid-sized Pharma

Industry: Life Sciences

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US-trained Drug Safety MD needed for Medical Director role with mid-sized Pharma

Our client, an exciting global mid-sized pharmaceutical company, is offering a unique opportunity for a US-trained drug safety physician with extensive industry experience.  This person will provide medical expertise in the review and evaluation of safety information for investigational and marketed products, including: evaluation of serious clinical trial adverse events and spontaneous reports of adverse events This position will be based in Northern New Jersey.  If you are looking for a challenge and an exciting environment, please read on.

If you are a drug safety physician looking to enhance your career, please email a word document of your resume to afiore@kleinhersh.com. If this opportunity does not match your interest, we have a number of additional roles that could work for you.

Responsibilities:

Assess the relationship between drugs and adverse events. Analyzes events individually and collectively, tracking etiologic and numeric trends in both serious and non-serious cases, to evaluate impact of product on exposed population.

  • Determines case reportability per local regulatory requirements and meets appropriate timelines for reporting.
  • Develops responses for submission to International Regulators, which support development, approval, sales & marketing of products and which accurately reflect both the potential risks and benefits to the target population.
  • Formulates and represents opinion to co-marketing partners and international regulatory agencies
  • Represents Product Safety on Local Project Teams.
  • Member of the Global Safety Board and International Project Teams for assigned products, serving as General Safety Officer for assigned compounds in development and marketed.
  • Responsible for the review and analysis of cumulative adverse event reports for marketed products and products in development, for the purposes of preparing Aggregate Reports for submission to global Regulatory Authorities.

Requirements:

Job Qualifications:

  • MD degree, US Board Certified / Eligible
  • 4+ years experience in pharmaceutical development or related industry
  • 1-2+ years experience in a role as a medical reviewer of adverse event reports
  • 2+ years in a role requiring knowledge of Disease pathology and physiology, pharmacology and therapeutics, International and US Regulatory Reporting Requirements for Product Safety, pharmaceutical development process
  • 2+ years in a role of preparing aggregate reports and submission ready responses to Regulators on pharmacovigilance issues
  • Ability to work effectively in cross-departmental, cross-organizational teams
  • Strong organizational skills, strong written and verbal communication skills, strong computer skills

Location:

  • Boston, MA
  • New York, NY
  • Philadelphia, PA
  • Newark, NJ 
  • Chicago, IL 

Compensation:

We are prepared to put together a very attractive offer depending on qualifications and experience (180K-210K base + bonus + stock + relocation, etc)
Excellent Benefits (Medical, Dental, 401k, etc.)

If you are a Drug Safety executive looking to enhance your career, please email a word document of your resume to afiore@kleinhersh.com. If this opportunity does not match your interest, we have a number of additional roles that could work for you.

Visit www.kleinhersh.com to view other job opportunities available through our company.

For additional information about this job, please contact: afiore@kleinhersh.com