Medical Reviewer​/Safety Reviewer III

Job Title:

Medical Safety Specialist II / IIIJob Description

• Provide timely medical assessment of reported clinical trial data and actively participate in safety surveillance activities for assigned studies.

• Review clinical trial data including laboratory results, vital signs, cardiac assessments, concomitant medications, and medical history, and communicate relevant safety findings to the Study Lead.

• Perform detailed review of safety‑related data from clinical trials for content, quality, potential study‑level trend identification, and adherence to regulatory guidance and study protocols using strong critical thinking skills.

• Monitor and respond to safety‑related queries directed to investigators, ensuring clear, accurate, and timely resolution.

• Conduct in‑house medical review of Case Report Forms (CRFs), including query resolution, preparation of addenda, and quality assurance of data listings.

• Organize files and budgets associated with multiple clinical studies, supporting efficient study management and documentation.

• Support and, where applicable, manage activities of regional contract Clinical Research Associates (CRAs) to help maintain data quality and protocol compliance.

• Provide medical support for adverse event reporting, including investigation and documentation of medical product experiences and in‑depth analysis of medical adverse events.

• Collaborate with Medical Affairs, Clinical, and Regulatory Affairs teams in preparing adverse event documentation for regulatory authorities such as the FDA.

• Contribute to medical communication activities by writing standard and customized responses to medical and scientific information requests from healthcare professionals and the lay community.

• Respond to complex inquiries that require detailed medical and scientific information beyond package inserts or standard letter databases, including appropriate handling of off‑label information.

• Deliver training on safety‑related topics internally and at investigator meetings, including guidance on serious adverse event reporting and CRF completion.

• Write study summaries and review protocols, investigator brochures, and IND annual updates to verify and ensure accuracy of safety data.

• Adhere to ICH, FDA, EMA regulatory guidance, departmental processes, and internal policies with minimal supervision, maintaining current knowledge of evolving safety surveillance standards.

• Present accurate and medically sound safety data, both orally and in writing, to internal and external stakeholders as needed.

• Bachelor's degree in a related health science discipline.

• Active Registered Nurse (RN) license.

• Minimum of 2 years of bedside clinical practice experience.

• Clinical pharmacy or PharmD background with hospital‑based experience strongly preferred.

• At least 1 year of drug safety experience preferred.

• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.

• Proven ability to present accurate and medically sound safety data in both written and verbal formats.

• Effective communication skills for delivering study‑related information to investigators and internal teams.

• Proficiency with Windows operating systems and Microsoft Word and Excel.

• Demonstrated experience in medical review of clinical data, including CRFs and adverse event information.

• Ability to work with minimal supervision while following regulatory guidance, protocols, and departmental processes.

• Experience in hospital or clinical environments with direct patient care responsibilities.

• RN or clinical pharmacy experience is strongly preferred.

• PharmD with hospital‑based experience is highly desirable.

• Candidates with overseas clinical…