Safety Scientist 1 at WIRB-Copernicus Group in Research Triangle Park, North Carolina

Job Description:

SUMMARY OF POSITION:

The Safety Scientist 1 is responsible for accurate and timely case processing tasks per internal and client-specific Safety Management Plans (SMPs).

EDUCATION REQUIREMENTS:

* BS/BA degree in Nursing or healthcare related field or PharmD, or biological science discipline or otherwise licensed/certification as a healthcare professional

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

QUALIFICATIONS/EXPERIENCE:

• Excellent working knowledge related to data entry using safety database applications, coding terms using MedDRA and/or proficiency in working in healthcare related database applications containing patient/medical information


• Robust understanding of industry-standard clinical trial safety and/or post-marketed pharmacovigilance processes and regulations


• Solid knowledge of Good Documentation Practices (GDP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP)


• Strong knowledge of safety databases, data entry platforms, adverse event data collection processes, medical information and adverse event call center processes, and/or product quality complaint processes


• Knowledge of drug-safety related ICH Guidelines, FDA 21 CFR 312.32, 314.80, and MedDRA and WHO Drug coding


• Strong attention to detail and accuracy in work output, teamwork and collaboration skills


• Customer service orientation towards internal and external stakeholders


• Advanced Microsoft Office skills, particularly in Excel, PowerPoint and Word

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successful y, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required.

• Perform assigned Case Processing tasks as documented in WCG SOPs and/or Client-specific SMPs


• May perform duties for assigned Case Intake tasks as documented in SOPs and/or client specific SMPs, as required.


• Document adverse event information, as required


• Prepare and distributes SUSAR line listings


• Review, extract data and additional information and accurately enters adverse event (AE) data from ICSR report from both investigational and post marketing products


• Interprets case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries


• Quality review of reports


• Monitor case flow timelines to ensure compliance and that non-compliances are explored and appropriately documented


• Oversees and/or implement query generation for clarification and reconciliation of AE reports


• Perform other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here


• Maintains excellent attendance and punctuality as these are essential for the position

SUPERVISORY RESPONSIBILITIES: None

TRAVEL REQUIREMENTS: Must be able to travel approximately 5% of the time