We are desiring to recruit a diligent Medical Reviewer/Safety Reviewer II to join our energetic team at US Tech Solutions, Inc. in South San Francisco, CA.
Growing your career as a Full-Time Medical Reviewer/Safety Reviewer II is a promising opportunity to develop competitive skills.
If you are strong in problem-solving, time management and have the right personality for the job, then apply for the position of Medical Reviewer/Safety Reviewer II at US Tech Solutions, Inc. today!
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.
Qualifications:• 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).
- 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 Client 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. 3-5 Years Experience Level.
Benefits of working as a Medical Reviewer/Safety Reviewer II in South San Francisco, CA:
● Excellent Benefits Package
● Room for Advancement
● Leading Industry Pay
No CV Required
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