Medical Reviewer

Location: Fully Remote (within the US)

Contract Length: 12 Months

Pay Rate: $28-32/hr

Medical Reviewer/Safety Reviewer

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 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.

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.

Top skills/requirements:

• Competent understanding of ICH/FDA regulations and guidelines affecting drug / device safety issues preferred.
• Strong critical thinking skills
• 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.
• Bachelor's degree with related health science background is required (e.g. RN, pharmacy experience)

Experience, education, and/or certification requirements:

• Bachelor's degree with related health science background is required (e.g. RN, pharmacy experience)
• At least 2 years clinical experience is required.
• At least 2 years Pharma 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.

Experience/Skills:

* 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.

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.