Global Safety Lead
vor 1 Monat
Located within CSL's GCSP department, the Director, Global Safety Lead provide safety expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and post approval on evaluation of benefit-risks, and implementation/maintenance of appropriate risk mitigation measures to safeguard patients and protect public health. (S)He will apply sound medical judgment for analysis and interpretation of clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation. Integrate safety risk management activities of the product into their medical, business, and regulatory context.
The role serves as the safety representative in the cross-functional development teams and post-marketing product teams. It is responsible for setting safety strategy for these global projects. Strong product knowledge is needed for success in the role.
The role ensures that the medical and process standards delivered in CSL are in alignment with the following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public:
- Complying with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities.
- Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure.
- Promoting the safe and effective use of medicinal products in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.
- Contributing to the protection of patients and public health.
The role interfaces with key high-level internal and external stakeholders, contributes to, and approves regulatory reports / submissions / queries.
The role provides strategic input into life-cycle and clinical development, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities.
RESPONSIBILITIES AND ACCOUNTABILITIES
Safety Surveillance and Risk Management: Chairs the safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and programs and from the post-marketing environment. Oversees the safety signal detection and medical signal evaluation process. Oversees analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Provides a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities.
Quality Management: Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards
Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.
Inspections: Participates as safety representative in inspections related to the assigned product(s), as required. Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function.
Clinical Safety Development of the CSL portfolio: Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products and maintenance for established products. Sets the strategy, reviews and approves key filing documents including ISS, SCS, and risk management plans. Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in CSL's studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions.
Safety Due Diligence Activities: May be involved as subject matter expert in activities related to the selection of potential product acquisitions through the due diligence process
Clinical Safety Representation: Chair the Safety Management Team (SMT) and represents GCSP in relevant cross functional teams. Acts as delegate / deputy for TA Head as assigned. Represents the company as safety subject matter expert in health authority meetings in relation to the assigned products/projects.
Trains and act as mentor of Junior levels in the organization: May contribute to the onboarding and mentoring of other member of the global team around a clear set of standards and strategic objectives.
JOB SPECIFICATIONS
Education
- MD (Medical Doctor) degree, international MD equivalent or advanced life sciences degree
- For MD two (2) years minimum working experience as a physician in patient care or minimum five (5) years relevant industry experience
- For advanced life sciences degree, five (5) years pharmaceutical / biotechnology industry experience, thereof at least three (3) years in a safety physician equivalent role.
Subject Matter Knowledge
- Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state
- Understanding the key components of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials
- Understanding of key manufacturing aspects relevant to the safety of own portfolio
- Independently performing qualitative and structured benefit-risk assessments for own products and across the therapeutic area portfolio
- Selecting the appropriate key benefits and risks, building a value tree, and articulating other important elements such as uncertainty, unmet medical need and alternative treatment options
- Identifying literature sources and specifying search terms/filters for the identification and evaluation of signals
- Incorporating real-world evidence (RWE) safety data into signal identification and signal assessment
- Prioritizing and escalating signals to the appropriate level in the organization
- Evaluating signals for causality; identifying, classifying, and determining the impact of risk and confounding factors; conducting follow-up investigations
- Identification, monitoring and signal management throughout the entire lifecycle of a product using the technology deployed at GCSP
- Predicting potential risks and drafting risk mitigation strategies based on preclinical data
- Developing and executing risk mitigation and minimization strategies across the product lifecycle
- Selecting and using appropriate tools to evaluate the effectiveness of risk minimization and mitigation measures.
- Structure, key stakeholders, and interdependencies of the PV system
- CSL's safety and benefit-risk governance framework
- Business environment of a pharmaceutical company and how safety decisions can impact other functions and patients.
- PV concepts (e.g., CIOMS, listedness/expectedness, causality assessment, common AE grading and coding conventions, ICSR management)
- PV documents and safety sections of documents (e.g. PBRER, RMP)
- Safety sections/required safety contributions to regulatory submission documents (e.g., as part of MAA, renewals, CTD, IB, etc.).
- Labelling principles and key regional differences in displaying safety info.
- Product development process, the relevant scientific principles, and roles of contributing functions (e.g., clinical development, toxicology, epidemiology, biostatistics, regulatory affairs)
- Relevant regulations and key regulatory milestones including timing of key opportunities to have an open dialogue with Health Authorities
- Conveying complex concepts through clear and concise messages
- Demonstrating two-way communication, by seeking and incorporating feedback to improve outputs and alignment
- Preparing and delivering professional presentations to colleagues, tailoring messages, and communication methods to the needs of the audience
- Demonstrating independent thinking and techniques to support position
- Engaging and influencing cross-functional stakeholders to ensure that safety is included in relevant discussions
- Providing appropriate direction . click apply for full job details
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