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Director, Regulatory Drug Safety

Chicago, IL

Posted: 10/11/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2434

Job Description


The Director, Regulatory Drug Safety manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies.

Responsibilities
  • Develops strategic priorities, processes and operating procedures to ensure compliance with appropriate regulations and quality standards for drugs from pre-approval to on-market support.
  • Responsible for drug safety surveillance and ensures safety of drug development activities consistent with the company’ s operating procedures, regulatory, and legislative requirements.
  • Performs review of adverse event reports to ensure that appropriate interpretation, consistency, and quality are applied to case assessments.
  • Participates in review of scientific literature to identify case reports that meet criteria for entry into safety database.
  • Performs review of adverse event and medication coding.
  • Provides support for investigator brochures, protocols, informed consent, final study reports as appropriate.
  • Manages the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary (PSUR, DSUR, etc.).
  • Provides input to key internal safety documents including Risk Management documents (REMS, RMPs), develops and updates expectedness guides.
  • Provides safety guidance for aggregate reports.
  • Oversees the drug safety and compliance functions to ensure that corporate financial and strategic goals are attained within reasonable risk tolerances.
  • Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements. Oversees the development and preparation of reports for company management as well as external regulatory agencies.
  • Creates and updates labeling documentation and product information for an assigned group of pharmaceutical or medical products, in order to optimize patient safety and minimize product liability risk.
  • Participates in the oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety.
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.
  • May work with data management in the ongoing development and maintenance of regulatory safety databases.

Requirements / Qualifications:
  • Advanced degree preferred (PharmD, PhD, MD, or DO). Bachelor’ s degree required.
  • 8-10 years of progressive pharmacovigilance experience in drug development for the pharmaceutical and/or biotech industry.
  • Strong knowledge of regulations, current industry practices, and interpretation and application practices.
  • Knowledge of global healthcare regulating bodies and FDA drug submission experience required.
  • Competencies: Written & Verbal Communication, Presentation skills, Facilitation skills, Teamwork & Collaboration, Project Management, Independent Judgement, Organizational skills, Attention to Detail, Professionalism

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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