JOB SUMMARY 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.

JOB 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 (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.

QUALIFICATION REQUIREMENTS (please indicate if 'preferred')

• The incumbent should possess M.D., MBBS, D.O. or equivalent combination of education and experience
• 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%)

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.