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Product Safety Leader

Reference Number: 3016
Location: Midwest

Our client is a global, research-based biopharmaceutical company.  They have asked us to assist them in their search for a Product Safety Leader.

The primary job functions for this position include human safety surveillance related to pharmaceutical products and medical devices and risk identification and assessment.  The analysis and interpretation of large amounts of safety data in specific therapeutic areas will be paramount, as will the written and oral communication of said analyses.  The effective functioning of product safety teams is an important responsibility.

Major tasks and responsibilities will include:

  • Safety Surveillance and Rick Identification and Assessment Risk Management - Applies current regulatory guidance for risk minimization to the Company’s product safety, RMP/REMS plans, as appropriate.
  • Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing.
  • Understands assigned products’ pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical AE profile.
  • Knowledge of clinical AE profile ranges from familiarity with individual case safety reports for assigned products to comprehension of aggregate safety data across clinical trials.
  • Develops core knowledge of adverse events commonly associated with pharmaceutical agents- including long QT syndrome, hepatotoxicity, bone marrow toxicity, drug-drug interactions, nephrotoxicity and immunogenicity- and expertise in one of these topics.
  • Ability to collaborate with internal and external relevant parties and develop a comprehensive risk management strategy for each of these topics.
  • Assists MSE and PV management in developing novel methods for signal detection using aggregate data from clinical trials, post market studies, epidemiological investigations and literature.
  • Tracks known safety issues and potential safety concerns throughout the products’ lifecycle (Product Safety Plan).
  • Communicates new safety issues or potential safety concerns to PV management and PST as necessary.
  • Spearheads efforts at the clinical team/PST level to further characterize and describe safety issues or potential safety concerns prior to NDA filing and foresee and help initiate post marketing opportunities for risk mitigation.
  • Evaluates potential safety signals through signal work-up.  Characterizes the signal work-up on safety topics for assigned product requested by internal and external.

We seek candidates with the following qualifications:

  • MD or equivalent with relevant therapeutic specialty in an academic or hospital environment required.  MPH is desirable.
  • Residency with direct patient management and care in patients in the following areas: Internal Med, Oncology, Cardiology, Infectious diseases, is preferred.
  • Completion of residency and/or fellowship is preferred.
  • Board certification is preferred.
  • At least 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or equivalent.
  • Proven leadership skills in a cross-functional global team.
  • Ability to interact externally and internally to support a global business strategy.
  • Ability to serve as internal consultant and collaborate with internal and external relevant parties.
  • Demonstrated experience in leading a small multi-disciplinary business team (or sub-team) consisting of 4-6 members.
  • Demonstrated experience in leading the medical review of premarketing and/or postmarketing data, and writing high quality technical reports.
  • Demonstrated experience in assuming primary responsibility for assembling the safety sections of responses to health authority questions for a drug product.
  • Effective oral presentation and communication skills.


Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3016. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.