Medical Reviewer/Safety Reviewer

Spectraforce Technologies; Avon (IL); Remote; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Spectrumforce Technologies, Inc. is seeking a Medical Reviewer/Safety Reviewer for a 24-month, fully remote engagement.

The role emphasizes timely assessment of clinical trial data and active participation in safety surveillance across study data, including labs and vital signs, with clear communication to the Study Lead. The candidate should have at least 2 years of bedside experience in hospital settings, and hold a Nursing or Pharm Bachelor's degree with RN or PharmD licensure.

Qualifikationen

• Minimum 2 years of bedside experience in hospital settings.
• Nursing or Pharm Bachelor's degree; RN or PharmD licensure required.
• Strong knowledge of ICH, FDA, and EMA regulatory guidance affecting safety surveillance.

Aufgaben

• Provide timely assessment of reported clinical trial data and participate in safety surveillance activities, reviewing labs, vital signs, cardiac data, medications, medical history, and communicate findings to Study Lead.
• Review safety-related data from clinical trials for content, quality, potential study-level trend identification, and regulatory adherence.
• Monitor safety-related queries to Investigators.
• Adhere to regulatory guidance, protocols, departmental processes and policies under minimum supervision.
• Stay current with knowledge of ICH, FDA, and EMA regulatory guidance affecting safety surveillance.

Kenntnisse

Bedside experience

Clinical data review

Regulatory awareness

Ausbildung

Bachelor's degree in Health Sciences

RN or PharmD licensure

Jobbeschreibung

Job Title

Medical Reviewer/Safety Reviewer

Duration

24 Months

Work Arrangement

100% Remote

MUST HAVES

• ** Minimum 2 years of bedside experience - nurses, pharm D (hospital settings) **
• ** With a Nursing or Pharm Bachelor's degree, RN or Pharm D licensure is required

SOFT SKILLS

• Energetic
• Clinical curiosity/competency
• Tech savvy for new systems

Job Description

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings.
• Provide review of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
• Monitoring of safety-related queries to Investigators.
• Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision.
• Current with knowledge of ICH, FDA, and EMA regulatory guidance's affecting safety surveillance.

Responsibilities

• Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
• May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies.
• 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; or 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.

• Off-label information would be disseminated at this level.
• May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

Qualification & Experience

• Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred.
• A minimum of 2 years of clinical practice experience is required and 1-year drug safety experience preferred.
• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.
• Ability to present accurate and medically sound safety data, both orally and in writing.
• Effective communication skills in delivering study-related information.
• Proficiency in Computers (Windows, Word, Excel).