Signal Detection, Evaluation and Labelling

Job description

TCS is hiring for Signal Detection, Evaluation and Labelling Qualification : Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or related healthcare field

• Runs routine signal detection process (including On-Line Signal Management Tool, literature review and, in partnership with product scientist, tools for individual case awareness) for all products in area or responsibility.
• Provides medical input to signal detection and subsequent evaluation for designated products in partnership with more senior physician Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
• Takes the lead role in data evaluation and discusses the results with the TA Director/product scientist and other key stakeholders (e.g. Clinical Development groups) Presents on labelling recommendations for complex issues to Global Labelling Committee or Global Safety Board, in partnership with product scientist Produces regulatory supporting documentation for labelling updates.
• Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue/ or medication errors; communicates with the product scientist/ TA Director and/or Manufacturing; documents outcome in consultation with the product scientist and Clinical Development representatives Regulatory Reports and Submissions

Qualifications

BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc), M.SC., MASTER OF PHARMACY