The position is responsible for performing medical review of Individual Case Safety Reports (ICSRs),
conducting medical assessement of all safety related data and ensuring medical accuracy of the ICSR
narrative, coding and appropriate medical interpretation of all cases.
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,
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
Performing other duties as assigned by management.
The incumbent should possess M.D., MBBS, D.O. or equivalent combination of education and
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%)