Senior Global Safety Leader Rare Disease Cell

3 months ago


Reading, United Kingdom Bayer Full time

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Senior Global Safety Leader Rare Disease Cell & Gene Therapy**

At Bayer Pharmaceuticals, we are dedicated to revolutionizing the healthcare industry through our cutting-edge research, development, and marketing of specialty-focused innovative medicines. Our mission is to provide significant clinical benefit and value to patients in therapeutic areas such as cardiology, oncology, gynecology, hematology, and ophthalmology. With nearly 50 ongoing development projects in clinical trials, we are a global leader in research-based pharmaceuticals.

**YOUR TASKS AND RESPONSIBILITIES**
- Lead the Benefit-Risk Management team, implementing state-of-the-art strategies to proactively monitor and assess the benefit-risk balance from early stages of clinical development
- Provide expert guidance on safety and benefit-risk balance to the Therapeutic Area Group Head, senior management committees, and external regulatory agencies
- Conduct comprehensive assessments of complex safety and benefit-risk topics using your extensive knowledge of clinical development, evidence-based medicine, and key pharmacovigilance areas
- Analyze available data from studies, adverse event reporting, and regulatory communication to detect and assess signals, providing high-quality aggregate reports and responses to regulatory queries
- Ensure ongoing benefit-risk assessment of assigned marketed products and implement risk management activities to optimize their safe use
- Represent Bayer in industry consortia focusing on benefit-risk and safety, while building and maintaining a strong network of external scientific consultants and advisory boards
- Collaborate with cross-functional teams to provide input on patient safety and benefit-risk balance, optimizing clinical development and life cycle management

**WHO YOU ARE**
- MD degree or equivalent (e.g., DO or MB) required
- Long-term clinical or industry experience, with a focus on patient safety and pharmacovigilance across the life cycle, including clinical development
- Deep knowledge of key pharmacovigilance topics and a strong understanding of the specific therapeutic area are essential
- Experience with interactions with major regulatory agencies
- Ability to engage with expert consultants and Key Opinion Leaders
- Familiarity with pharmacovigilance regulations and evidence-based medicine concepts
- Strong influencing skills and the ability to defend positions effectively
- Strategic mindset with proactive planning and prioritization abilities
- Effective team player who takes ownership and delegates appropriately
- Proficient in operating within a collaboration model and governance framework
- Outstanding analytical, problem-solving, and document review skills

LI-GH

**Location**:
United Kingdom : Berkshire : Reading

**Division**:
Pharmaceuticals

**Reference Code**:
794347



  • Reading, United Kingdom CSL Behring Full time

    ABOUT CSLCSL is a leading global biotechnology company with a constantly evolving portfolio of lifesaving products, built from the company’s passion to always put patients and people first.Headquartered in Melbourne and listed on the Australian Stock Exchange, CSL provides life-saving medicines in more than 60 countries and has over 32,000 employees...


  • Reading, Reading, United Kingdom Liberty Global Full time

    Liberty Global seeks a seasoned and driven Director of Security Design Engineering Assurance to lead our security design project assurance initiatives across all product and technology solutions. This pivotal role demands a strategic leader with a deep understanding of information security principles and a proven track record in managing multi-functional...


  • Reading, Reading, United Kingdom Liberty Global Full time

    Liberty Global seeks a seasoned and driven Director of Security Design Engineering Assurance to lead our security design project assurance initiatives across all product and technology solutions. This pivotal role demands a strategic leader with a deep understanding of information security principles and a proven track record in managing multi-functional...


  • Reading, Reading, United Kingdom Liberty Global Full time

    Liberty Global seeks a seasoned and driven Director of Security Design Engineering Assurance to lead our security initiatives across all product and technology domains. This pivotal role demands a strategic thinker with a proven track record in information security, adept at navigating complex global organizations. You will spearhead the development and...

  • Practice Nurse

    2 days ago


    Reading, Reading, United Kingdom Westwood Road Health Centre Full time

    About Westwood Road Health CentreWe are a rapidly growing GP-led organisation with a mission to ensure that all patients have access to comprehensive, coordinated and continuous care within a sustainable primary care system.Job SummaryWe are seeking an experienced Practice Nurse to join our team at Westwood Road Health Centre. The successful candidate will...

  • Cra2/scra

    3 months ago


    Reading, United Kingdom Novasyte Full time

    THE ROLE: - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with Good Clinical Practice - Administer protocol and related study training to assigned sites - Manage the progress of assigned studies by tracking regulatory submissions and approvals. - Create and maintain appropriate documentation regarding...


  • Reading, Reading, United Kingdom Liberty Global Technology Services BV Full time

    About Liberty Global Technology Services BVWe're a world leader in converged broadband, video, and mobile communications, and an active investor in cutting-edge infrastructure, content, and technology ventures.Our company plays a vital role in society, providing over 85 million fixed and mobile connections and rolling out the next generation of products and...


  • Reading, United Kingdom Brightsmith | B Corp™ Full time

    Senior Process Engineer – Renewable energybrightsmith are proud to partner with a leadingtechnology company based in the UK to expand their team. This is an opportunity for purpose driven experts to join a business launching products into multiple sectors globally and commencing a period of growth and change. The company is in transition from an R&D...


  • Reading, Reading, United Kingdom Liberty Global Technology Services BV Full time

    ABOUT US At Liberty Global Technology Services BV, we are dedicated to shaping the future of connectivity, uniting individuals through innovative technology. As a prominent player in the realm of integrated broadband, video, and mobile communications, we actively invest in state-of-the-art infrastructure, content, and technology initiatives. Our commitment...

  • Senior Biostatistician

    3 months ago


    Reading, United Kingdom Novasyte Full time

    Senior Biostatistician Global Biostatistics Home-Based/Hybrid: EMEA & UK LI-Remote LI-Hybrid Join us on our exciting journey! The Global Biostatistics (Data Sciences, Safety & Medical) team at IQVIA are experienced in submissions for all major regions; working together with key groups such as, Global Regulatory Affairs, Safety, Project and Data...


  • Reading, United Kingdom Liberty Global Technology Services BV Full time

    ABOUT US We’re building Tomorrow’s Connections Today, bringing people together through the power of our technology. Liberty Global is a world leader in converged broadband, video and mobile communications and an active investor in cutting-edge infrastructure, content and technology ventures. With our investments in fibre-based and 5G networks...


  • Reading, Reading, United Kingdom Chemistree Solutions Full time

    Senior Health Economist. Exciting opportunity working for an established pharmaceutical companyRole: Senior Health EconomistTherapy Area: PharmaceuticalsPackage: Competitive packageLocation: Hybrid - Home Based and 2 days per week in Berkshire Head OfficeThis role will be working on a contract until end of December 2024This is a great chance to join a top...

  • Bone Marrow Transplant

    3 months ago


    Reading, United Kingdom Royal Berkshire NHS Foundation Trust Full time

    An exciting opportunity has arisen within the Haematology department for a Bone Marrow Transplant (BMT) Clinical nurse specialist. we are looking for a motivated, dynamic, forward thinking nurse with an experience in Haematology. The post holder will; Be involvedin the pre and post care of all patients undergoing Peripheral Blood Stem Cell Transplants. Be...


  • Reading, United Kingdom Global Radio Services Full time

    Commercial Scheduling Team Leader - Distribution and National Copy **Reporting of the Role**: This role reports to the Commercial Scheduling Director **Overview of job**: This role is to lead the Distribution and National Copy Teams that sits within the Commercial Scheduling Dept. You will work as part of the team and also take responsibility when...

  • Production Line Leader

    3 months ago


    Reading, United Kingdom Legrand North America Full time

    Position Description: **Date**: November 2022 **Job Code**: **Job Title**: Production Line Lead BWP/BWF** **Job Classification**: **Company**: Starline **Role**: Directs activity of line and acts as expert for builds, safety, quality, and testing issues. Engages in direct problem solving to mitigate production flow constraints through direct intervention or...


  • Reading, Reading, United Kingdom Hays Senior Finance Full time

    Senior Audit Supervisor Our client is seeking a dedicated Senior Audit Supervisor to join their Audit & Assurance division. This position is crucial for the growth and success of the audit service line. We are looking for a skilled audit professional with managerial experience who is passionate about delivering high-quality audit services. Key...


  • Reading, Reading, United Kingdom Principal People Recruitment Full time

    Principal People are pleased to working with a global leader in insurance, risk management and consulting services who are looking for a Health and Safety Consultant to join their Risk Management Solutions team West of London. The focus of this role is to help clients calculate risk exposure; you will use your technical expertise, commercial skills and good...


  • Reading, United Kingdom Wood PLC Full time

    JOB DESCRIPTIONWood is currently recruiting for contract Senior and Principal Technical Safety Engineers to provide services to our Technical HSE Team based in Reading.You will be working alongside the Design HSE Group, within the Engineering Department, and will liaise with the Group Manager Design HSE. The department sits within the New Energies business...


  • Reading, United Kingdom Wood PLC Full time

    JOB DESCRIPTIONWood is currently recruiting for contract Senior and Principal Technical Safety Engineers to provide services to our Technical HSE Team based in Reading.You will be working alongside the Design HSE Group, within the Engineering Department, and will liaise with the Group Manager Design HSE. The department sits within the New Energies business...


  • Reading, United Kingdom Global Radio Services Full time

    Commercial Scheduling Team Leader, CCUK (Reading) **Reporting of the Role** This role reports to the Group Manager, Commercial Scheduling **Overview of job** This role is to lead the CCUK Commercial Scheduling Team. You will work as part of the team and also take responsibility when escalation occurs. This is a senior role within the team. You will be...