At a Glance
- Tasks: Lead global safety strategies and manage clinical safety data for innovative therapies.
- Company: CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Comprehensive benefits package, including health support and a focus on well-being.
- Other info: Join a diverse team committed to innovation and inclusion.
- Why this job: Make a real impact on patient safety and contribute to groundbreaking medical advancements.
- Qualifications: MD or equivalent, with experience in clinical safety and pharmaceutical industry.
The predicted salary is between 54000 - 66000 £ per year.
Located within CSLB’s GSPV department, the Director, Global Safety Lead, Formulation Safety provides 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. (S)He will apply sound medical judgment for analysis and interpretation of complex 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 CSLB 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.
Responsibilities and Accountabilities
- Safety Surveillance and Risk Management: Oversees safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials 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.
- 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: 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 CSLB 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. Sets the strategy, reviews and approves key filing documents including Integrated Summary of Safety (ISS), Summary of Clinical safety (SCS), and risk management plans (RMPs). 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 CSLB’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.
- Clinical Safety Representation: Chairs the Safety Management Team (SMT). Represents GSPV in relevant cross functional teams.
Qualifications:
- Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
- Two (2) years minimum experience as a physician in patient care.
- 3+ years pharmaceutical / biotechnology industry experience, with 1 of which include accountability for medical oversight/evaluation or clinical development.
- Industry experience in designated therapeutic area(s).
- Experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit.
Summary
Location: Americas, US-PA, King of Prussia, CSL Behring; EMEA, GB, Berkshire, Maidenhead, CSL Behring; Americas, US-MA, Waltham, CSL Behring; EMEA, CH, Glattbrugg, CSL Behring
Type: Full time
Global Safety Lead - Formulation Safety in Maidenhead employer: CSL
As an Associate Director in Procurement Enablement at CSL, you will be part of a forward-thinking organisation that prioritises sustainability and governance while fostering a culture of continuous improvement and talent development. With a commitment to employee growth through the Global Procurement Academy and a collaborative work environment, CSL offers a unique opportunity to influence procurement practices on a global scale, making it an excellent employer for those seeking meaningful and impactful careers.
StudySmarter Expert Advice🤫
We think this is how you could land Global Safety Lead - Formulation Safety in Maidenhead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CSL. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like CSL.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like CSL. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what CSL is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Global Safety Lead - Formulation Safety in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CSL!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show CSL that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at CSL!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At CSL, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at CSL
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CSL that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with CSL’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
