Safety Officer

Location: Flemington, NJ

Travel: 0-10%

Overview:

Responsible for the day-to-day processing and follow-up of all serious adverse events and other events of medical interest, under the direction of the Chief Delivery Officer and in conjunction with the Senior Medical Personnel and Regulatory Team at Beardsworth.

A. Essential Functions:

• Process adverse events according to Beardsworth SOPs and project specific safety plan.
• Ensure completeness and accuracy of adverse event worksheet and source documents.
• Will determine follow-up requirements and formulate and generate queries.
• Interact closely with clinical and medical monitors, investigative site personnel and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved.
• Accurately enter and verify data fields in BNet and our ExPERT (Adverse Event Reporting System [AERS]) or sponsor database.
• Code all adverse events, indications, medical history and medications.
• Interpret adverse event data to help identify safety trends.
• Prepare narratives.
• Provide periodic SAE and AE reports to Chief Delivery Officer, Project Manager, sponsor, IRB and others as requested by Chief Delivery Officer.
• Perform case quality assurance checks.
• Interact with Data Management and sites as required to reconcile / resolve discrepancies between the clinical and safety database.
• Reviews safety and medical information for assigned projects, including safety components of protocols.
• Prepare data for SMC / DSMB review; contribute to annual report production.

B. Secondary Functions:

• Provide safety input to project plans and study documents.
• Train and support project team on safety issues and regulatory inquires.
• Support consistent safety communications for study.
• Conduct staff education on safety issues.
• Other duties as assigned.

C. Skills Required:

• Good clinical interpretation skills based on limited information along with strong understanding of medical terminology.
• Solid knowledge of and experience in interpreting and applying global pharmacovigilance and risk management regulations and guidelines.
• Demonstrated ability to analyze safety signals/issues.
• Effective, accurate, and concise communication expertise with multiple levels of the organization.
• Close attention to detail with absolute commitment to quality.
• Meets timelines reliably with quality deliverables.
• Possess integrity plus high standards of ethical conduct in dealing with confidential information and projects.
• Appropriately represent Beardsworth when building and maintaining relationships with sponsor, sites, and employees; ability to build trust and confidence in teams/departments.
• Computer proficiency.

D. Education/Work Experience:

• Bachelor’s degree or higher in a Life Science, BSN preferred or PA-C.
• Registered Nurse with experience in clinical research.

 

Please contact or fax your CV, with salary requirements and contact information to (908) 788-5281, ATTN: Human Resources.