Safety Risk Leads (SRLs) perform proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection & evaluation, risk assessment and safety risk minimization.
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 but Oncology). SRLs may act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety.
In summary the SRL performs proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection, risk assessment and safety risk minimization.
Colleague capability (see separately available SRL capabilities and responsibilities continuum) will drive Nature and Complexity of Assigned Responsibilities and Activities:
• The 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 but mainly Oncology. They will collaborate closely with the relevant WWS Safety Strategy Oncology Head to support the BU safety strategies.
- The SRL obtains guidance from the relevant WWS Safety Strategy Business Unit/Research Unit Leads to meet the BU/RU Safety Strategy goals.
- The SRL 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.
• The SRL provides and accumulates DA-specific pharmacovigilance expertise, and applies 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”.
• The SRL performs 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).
• The SRL ensure 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.
• The SRL performs 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.
• The SRL identifies 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 opportunities.
•The SRL may lead innovating, championing and implementing Novel Approaches to SS & RM across BUs: engagement in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
• The SRL may contribute to additional Centers of Excellence (e.g. Vaccines, Safety Advisory Councils, Contributions to or coordination of Other Pan-BU/RU activities).]
• The SRL participates in inspection readiness and support. of the SRL provides data to project managers for metrics and activity tracking.
• Further; The SRL will be
- Providing SS & RM support for a particular product, across the product’s multiple use in different BUs
- Providing SS & RM support for a particular product in a BU, within and across the product’s multiple indications in a BU
- Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence in-licensing assessments
- Focusing intra- and inter- DA-Cluster sharing of information between related areas (e.g. safety knowledge of Pain vs Inflammation co-prescribing)
- Enabling “matrix assignment” from within SSRM to supporting WWS Group Heads.
• The SRL may work across more than one SSRM DA or DA-Cluster as appropriate to business need. The SRL may support product teams locally or globally (remote).
• The SRL may be assigned to chair/lead/support various Safety Management Teams (e.g. RMC and RMC CWGs etc.), on one or more products or group of products, for one or more Business Units.
(Note: “BU” used herein = BU/RU).
Qualifications
Colleague capability (see separately available SRL capabilities and responsibilities continuum) will drive Nature and Complexity of Assigned Responsibilities and Activities.
• MD (physician)
• DA-specific knowledge is preferred.
• Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
• Displays a sound understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of drug development process.
• Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.
• Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to- day activities and collaborative skills.
• Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
• Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
• Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues’ diverse opinions and bringing group to consensus. Next steps and actions are clear.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.
• See also Technical Skill Requirements section.
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