Assess the benefit/risk of assigned products, working with other Client functional groups within. Ensure strategy and level of surveillance for allocated portfolio of medicinal products is appropriate for the product and any issues surrounding the product. Makes recommendations on actions required to maintain a positive benefit/risk profile of their products and is responsible for strategy for risk minimization if required.
Provides strategy, medical expertise, review and medical expert signoff of aggregate reports prepared by R&D, OCMS and GMS for regulatory authority submissions, scheduled and ad hoc reviews of safety topics and other documents relevant to the safety of assigned products.
Advises on the appropriate strategy for regulatory authority submissions of safety data in support of license application and provide input into development of safety elements of the submissions and/or Development Plans as required.
Assess proposed safety data accumulation in clinical studies and other relevant studies performed during pre and postauthorisation phases of the product development, and review safety findings from the studies. Assess the presentation of safety data in the study report, Present findings.
Advises and researches implications on health of manufacturing or product quality issues.