Description
Responsibilities include:Reviews individual case reports series and aggregate safety data
Under guidance of and approval of MSO, prepare, draft and write ad-hoc responses to regulatory queries and aggregate safety assessment reports
Co-ordinates preparation of ad-hoc safety reports by vendors and Global Medical Safety (GMS)
Liaises with MAF, R&D and pre-clinical sciences to obtain any new information relevant to the benefit/risk profile of assigned products
Assists with assessment of safety implication of product quality issues
Assists in the development of Risk Management Plans
Contributes to the development of labelling for assigned products
Ensures that each safety issue is assessed within agreed timelines and communicated to stakeholders
Ensures filling of the developed documentation
Contributes to the development of surveillance/data assessment tools in support of ad hoc surveillance.