Safety Physician

Job Summary

Safety Physician

Responsibilities

• Performs medical review of adverse events reported for investigational and marketed products
• Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS.
• Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
• Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information
• Identifies, communicates and effectively manages potential safety issues
• Interacts with client s safety/medical personnel as appropriate
• Stays abreast of clinical and drug development information relevant to contracted programs
• Provides medical review and interpretation for aggregate safety reports (eg annual safety reports, PSURs, PADERs)
• Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education
• Assists as a mentor and trainer for other internal safety staff including case processing staff
• Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines
• Performing other duties as assigned by management.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.