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Medical Reviewer/Safety Reviewer II

A Line Staffing Solutions

This is a Contract position in Lexington, KY posted December 16, 2021.

Medical Reviewer/Safety Reviewer II openings in the Waukegan, Illinois area with a major pharmaceutical company Starting ASAP Apply now with Luke H.

at A-Line Job Summary: 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.

Pay: $28
– $32 hourly Schedule: 40 hours/week and 8 hours/day Monday-Friday (flexible start and end times) Required Qualifications: Bachelor’s Degree with related health science background preferred; Candidates lacking the appropriate Bachelors degree but with previous pharma experience may be additionally considered.

RN or clinical pharmacy experience strongly preferred.

At least 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.

Responsibilities: 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.

Why Apply: Full benefits available after 90 days: Medical, Dental, Vision, Life, Short-term Disability 401k after 1 year of employment: With employer match and profit sharing GREAT Hours Monday through Friday, 40 hours per week Competitive Pay Rate Keywords: CMC, QC, QA, Pharma, Biotech, Technical Writer, Documentation Management, Medical Writing, Clinical Research, Regulatory Affairs, Regulatory Compliance, Quality Assurance, Clinical, Pharmaceutical, Quality Control, Medical Writing, Clinical Regulatory documents, Trial Master File, TMF, ICH, GCP Guidelines.

Job Requirements: Required Qualifications: Bachelor’s Degree with related health science background preferred; Candidates lacking the appropriate Bachelors degree but with previous pharma experience may be additionally considered.

RN or clinical pharmacy experience strongly preferred.

At least 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.

Keywords: CMC, QC, QA, Pharma, Biotech, Technical Writer, Documentation Management, Medical Writing, Clinical Research, Regulatory Affairs, Regulatory Compliance, Quality Assurance, Clinical, Pharmaceutical, Quality Control, Medical Writing, Clinical Regulatory documents, Trial Master File, TMF, ICH, GCP Guidelines.