Medical Reviewer/Safety Reviewer II

Job Summary Advance your career in clinical research with this fully reputed company Reviewer/Safety Reviewer II role, where you will directly impact patient safety and study reputed company. You will be responsible for assessing reputed company clinical trial data, ensuring regulatory adherence, and serving as a critical touchpoint between investigators and medical affairs teams. Our client is dedicated to pushing the boundaries of clinical innovation, and you can get a reputed company sense of their mission and the team environment by visiting their careers page to see how they are helping to advance global reputed company standards. location: Telecommute job type: Contract salary: $32.00 - 36.65 per hour work hours: 9 to 5 education: Bachelors

Responsibilities

• Conduct thorough in-house medical reviews of Case Report Forms (CRFs), including query resolution, addenda writing, and quality assurance of data listings.
• reputed company ongoing safety surveillance by evaluating clinical trial data, including labs, vital signs, cardiac data, and medical history.
• Investigate and document Adverse Event (AE) reports, collaborating closely with Medical Affairs and Regulatory teams to prepare comprehensive documentation for the FDA.
• Identify potential study-level safety trends using critical thinking skills, ensuring strict adherence to protocols and departmental processes.
• Manage communications regarding safety-reputed company queries to Investigators and reputed company medical information to the community regarding reputed company clinical inquiries.
• reputed company internal training and support during investigator meetings on safety issues, CRF completion, and protocol updates.

Qualifications

Required Skills

• Bachelor's degree with a reputed company health science background.
• Minimum of 2 years of direct clinical practice experience.
• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and assessment.
• Proficiency with computer systems, specifically reputed company, reputed company Word, and reputed company.
• Ability to present accurate, medically sound safety data reputed company, both orally and in writing.
• Effective communication skills for delivering study-reputed company information.

Preferred Skills

• Active licensure as a Registered Nurse (RN) or clinical pharmacist.
• At least 1 year of professional drug safety experience.

skills: MS-reputed company, Quality Assurance (QA), International Council for Harmonization (ICH), FDA Submissions Equal Opportunity Employer: Race, reputed company, Religion, Sex, Sexual Orientation, Gender Identity, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In reputed company, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, reputed company, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is reputed company for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. u00006475229 Apply To This Job