Principal/Associate Director, Safety Physician (New Modality)

• Be responsible for the Clinical Safety strategy for assigned projects and products throughout all stages of development, including implementation and communication of the strategy at the project team/governance level.

• Reviews and endorses the Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).

• Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the PRMP, CPRL and globally reviewed LRMPs.

• Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.

• Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.

• Provides strategic clinical safety input into Clinical Development planning activities.

• Provides strategic and medical input to project specific safety require...