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Drug Safety Scientist

Lake Zurich, Illinois 60047

Post Date: 05/09/2018 Job ID: 1971 Job Category: Clinical: Scientific

Receives, assesses, investigates, processes, and reports adverse drug events regarding company drug products. Participates in global data exchange with company entities and other partners. Interacts with the Quality and Regulatory Departments to resolve safety and quality issues.

Job Responsibilities:
  • Receives, assesses, processes, and investigates adverse drug events in accordance with global and local SOPs, and FDA regulations and guidelines.
  • Maintain attention to detail in reviewing, assessing and processing adverse drug events.
  • Utilization of critical thinking skills.
  • Reviews and assesses the medical literature for adverse drug event case reports. May assist the global Adis Coordinator as required, insuring the alert settings and the literature search profile in the Adis database is up to date.
  • Participates in the preparation of adverse event Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR), and expedited case reports.
  • Maintains current knowledge of applicable local and global regulations, standard operating procedures, and guidelines. Maintains an in-depth understanding of product knowledge, labeling, and relevant data for company products. Maintains knowledge of all pertinent regulatory safety publications.
  • Interacts with the Quality and Regulatory Departments to resolve safety and quality issues.
  • Maintains a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.
  • Additional tasks and responsibilities as required.

Qualifications/ Requirements:
  • Medical/clinical professional degree required i.e., PharmD, RPh, RN degree.
  • Minimum 3 years of drug safety and adverse drug event reporting experience required. Pharmaceutical industry experience preferred.
  • Experience with preparation of adverse event Periodic Adverse Drug Experience Reports (PADER), or Periodic Safety Update Reports (PSUR) is preferred.
  • Clinical/hospital experience preferred.
  • Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a product quality issue.
  • Ability to gather data from multiple sources and references and formulate a medically-appropriate case narrative.
  • Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards (signal detection).
  • Must be able to prioritize and multi-task with minimal supervision, and participate in peer-review process when processing product complaints and adverse drug events.
  • Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required. Lotus Notes experience preferred.
  • Excellent written and verbal communication skills required.

Dorie McCrann
Senior Clinical Recruiter

Dorie is a great listener who connects easily with candidates and clients. She brings 18 years of full life-cycle recruiting experience to The Steely Group, and attributes her success to a customer-focused approach, attentive communication, and strong networking skills.

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