Signal Detection

Qualification:  Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, or related healthcare field

2. 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.

3. 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

4. Co-ordinates the compilation of large PSURs requiring a GCSP team approach and provides high level summaries on major issues.

5. 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

6. 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.

7. Advices on the preparation of licensing agreements in therapeutic areas of responsibility Participates (along with product scientist) in internal meetings with project focus</span