Safety Risk Leads (SRL) in SSRM may be assigned as the product safety-management-team (e.g. Risk Management Committee) Chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs. They will collaborate closely with the relevant WWS Safety Strategy Business Unit/Research Group Heads tosupport the appropriate BU safety strategies.
o The SRL obtains guidance from the relevant WWS Safety Strategy Business Unit/Research Unit Leads to meet the BU/RU Safety Strategy goals.
o SRLs may be assigned to act as a Safety Point of Contact to the Asset Teams, ensuring a unified communication on safety matters for WSR/WWS.
Providing and accumulating DA-specific pharmacovigilance expertise, and applying this to various BUs products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a Centre of Excellence.
Performing frequent proactive Holistic Safety Review for products, across the span of relevant available safety data information. Reviews are incremental, cumulative and aggregate, to include the body of safety information available from WWS/WSRO and elsewhere (e.g. clinical, epidemiology, spontaneous, literature & regulatory cases, other scientific data).
Ensuring Consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WSR/SER Authors.
Performing ad hoc special scholarly SS & RM activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
Identifying opportunities for Consistency and Standards for SS & RM approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
Innovating, championing and implementing Novel Approaches to SS & RM across BUs: engagement in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
Platform for additional Centers of Excellence (e.g. Vaccines, Safety Advisory Councils, Contributions to or coordination of Other Pan-BU/RU activities).
Engagement in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.
o Providing SS & RM support for a particular product, across the products multiple use in different BUs
o Providing SS & RM support for a particular product in a BU, within and across the products multiple indications in a BU
o Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence in-licensing assessments
o Focuses intra- and inter- DA-Cluster sharing of information between related areas (e.g. safety knowledge of Pain vs Inflammation co-prescribing)
o Enables matrix assignment from within SSRM to supporting WWSGroup Heads.