Monitoring the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and respond to safety related questions effectively.
Perform medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees.
Identify safety signals based on the review of solicited or unsolicited single cases. Performing signal detection, monitoring and evaluation of all safety signals.
Contributing towards responses to inquiries from regulatory authorities or health care professionals on safety issues.
Preparing safety data for Health Authority review boards. Providing inputs to responses for legal queries and Country Organization requests involving safety issues.
Providing expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
Collaborate efficiently on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
Contribute to the development of departmental goals and objectives.
Qualifications
At least 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience).
Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications is desirable.
Proven ability to analyze, interpret, discuss, and present safety information
Experience in preparing or contributing to preparation of clinical safety. assessments and regulatory reports involving safety information
Education
Medical Degree preferred.
Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field can also be considered for candidates with more extensive experience in patient safety.
