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Medical Reviewer/Safety Reviewer

  • Job reference: 935649
  • Location: Waukegan, Illinois
  • Salary: GBP240 - GBP256 per day
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 25/05/2021

Orion Group US are partnered with a global pharmaceutical company to hire an experience Medical/Safety Reviewer. We especially welcome applications from RN's and Pharmacists with experience in a clinical setting.

Responsibilities include:

  • Medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
  • Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA
  • Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.

Experience/Skills

  • Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred.
  • Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
  • 2 years clinical experience is required.
  • Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
  • Sound understanding of product labeling/literature, including safety profile.
  • Able to apply clinical knowledge to adverse event data collection and assessment.
  • Adheres to policies and regulations.
  • Must be Computer proficient (Windows, Word, Excel).

Job Description:

  • Collects, analyzes and triages adverse events and reviews safety-related data from clinical trials including adverse event reporting
  • medical review including labs, vital signs, cardiac, medical history
  • Participate in safety surveillance activities for assigned products, including assisting with regulatory responses and ad hoc data analysis
  • Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.
  • Adherence to regulatory guidance, Protocols, and departmental processes under minimum supervision

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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