Safety Physician

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 (e.g. 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.

Qualifications

What we re looking for
The incumbent should possess M.D., MBBS, D.O.
Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice
Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working in pharmacovigilance/epidemiology preferred
Knowledge of global pharmacovigilance regulations and processes
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet.
Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform and influence
Ability to travel as necessary (up to 10%)