Signal Detection

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

• Authors periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines.
• Co-ordinates the compilation of large PSURs requiring a GCSP team approach and provides high level summaries on major issues.
• Supports the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market Provides medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal documentation submitted to regulatory agencies, under supervision of more senior physicians.
• Authors the safety contribution to global regulatory submissions for new products, formulations or indications, in partnership with the product scientist and liaison with other functional experts (e.g. Clinical Development, regulatory) Other Alligned Activities 1.

Contributes to and/or reviews the safety team component of Safety Data Exchange Agreements and escalates any deficiencies to the TA Director to ensure quality and integrity of agreement. 2. Advices on the preparation of licensing agreements in therapeutic areas of responsibility Participates (along with product scientist) in internal meetings with project focus</span

Qualifications

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