Head of Pharmacovigilance

London, London Orchard Therapeutics

Posted 2 days ago

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Job Description

Permanent

 Location: Boston, MA or London, UK

Reporting to: Vice President, Clinical Development

Job Summary

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and its U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

The Head of Pharmacovigilance will be responsible for leading Pharmacovigilance for Orchard, driving patient safety, regulatory compliance, and the meeting of Company objectives. They will ensure the monitoring and communication of the safety of the Company products to both internal and external stakeholders throughout the clinical development to market life cycle.  This will be achieved using cost-effective, up to date, globally compliant processes.

This is a unique opportunity to join an agile and progressive team who are working to bring innovative therapies to patients. 

RESPONSIBILITIES

  • Leads the development and execution of a strategic, globally aligned approach to product safety across development and post-marketing, including but not limited to:
    • Bringing expertise through the writing of clinical development plans, protocols, and study reports, aggregate analyses (PBRERs / DSURs), regulatory submissions (BLA/NDA/MAA dossiers, briefing documents, Risk Management Plans, REMS), and post-marketing commitments.
    • Creating detailed reports and evaluations of benefit-risk for internal audiences and external regulatory stakeholders.
    • Driving proactive, continuous risk assessment to optimize the benefit-risk profile of all products in the development pipeline and on the market.
  • Ensures the implementation and governance of a compliant Pharmacovigilance system consistent with industry best practices that:
    • Enabling real-time monitoring and benefit-risk assessment throughout the product lifecycle including post-marketing surveillance and post-approval commitments,
    • Meeting global regulatory requirements, and advances Company strategic objectives while safeguarding patient safety,
    • Ensuring high-quality Standard Operating Procedures are described within a robust Pharmacovigilance System Master File.
  • Provides strong leadership to cultivate a high-performance, results-driven, inspection ready culture within the Pharmacovigilance department. Actively coaches and mentors staff to support career growth, while building and sustaining a high-performing global team. Ensures all team members are accountable for delivering activities in a timely, accurate, and high-quality manner through leadership by example.
  • Ensures a high profile for the Pharmacovigilance department through regular collaboration and alignment with other senior management including other functional leads.
  • Takes an active and effective role on Company Committees governing safety activities
  • Effectively leads the Pharmacovigilance Department during the conduct of regulatory agency inspections and internal audits in close collaboration with GVP QA.
  • Plans Pharmacovigilance resources and activities to support clinical programs including creation and management of departmental budget and oversight and management vendors

Requirements

Experience

  • Extensive experience in pharmacovigilance leadership roles in biotech/pharma and/or regulatory agencies
  • Extensive knowledge of Pharmacovigilance best practices and international regulatory requirements (EMA, MHRA, FDA and, ideally, PMDA), including relevant GCP/ICH guidelines
  • Proven experience interacting with Regulatory Authorities for IND, NDA, BLA, and MAA submissions
  • Experienced in the implementation of commercial drug safety databases and managing software supporting global Pharmacovigilance operations
  • Gene therapy/ultra rare/orphan diseases background strongly desired

Skills & Abilities

  • Demonstrated ability to develop and implement global PV strategy and maintain a compliant, inspection-ready system
  • Skilled in working within matrixed, global organizations and successfully collaborating with international cross-functional teams
  • Proven leadership in pharmacovigilance with ability to build high performing PV teams and drive change in dynamic, cross-cultural environments
  • Strong strategic and operational acumen, able to lead teams while contributing hands-on
  • Exceptional communication and influencing skills, including confident engagement with regulatory authorities and key stakeholders
  • Decisive, accountable, and proactive problem-solver with strong analytical and organizational skills
  • Collaborative and solution-oriented mindset with a track record of delivering in fast-paced, complex settings

Education

  • Medical degree desired, ideally with a relevant post-graduate qualification (e.g., MRCP, MRCS, MFPM, MD). Experienced candidates with an advanced degree (e.g, PharmD., Ph.D.) will also be considered.
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Clinical Research Scientist

SW1A 0AA London, London £65000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client, a pioneering pharmaceutical company, is looking for an innovative Clinical Research Scientist to contribute to groundbreaking drug development from the comfort of their home. This is a fully remote position, offering the flexibility to work from anywhere within the UK, with a focus on designing and executing clinical trials that will shape the future of medicine. You will be responsible for the scientific integrity of clinical studies, from protocol development through to final study report.

Key responsibilities include analyzing complex data sets, interpreting results, and presenting findings to internal stakeholders and regulatory bodies. You will collaborate closely with cross-functional teams, including statisticians, medical writers, and regulatory affairs specialists, to ensure compliance with all relevant guidelines and regulations. This role demands a deep understanding of pharmaceutical research methodologies, statistical analysis, and regulatory requirements (e.g., GCP, ICH). A PhD or equivalent in a relevant life science discipline (e.g., pharmacology, biochemistry, molecular biology) is highly preferred, along with a proven track record of successfully managing clinical trials.

The ideal candidate will possess exceptional analytical skills, a meticulous attention to detail, and the ability to work independently with minimal supervision. Strong written and verbal communication skills are essential for documenting research, writing manuscripts for publication, and presenting scientific information clearly and concisely. You should be adept at managing multiple projects simultaneously and meeting tight deadlines. This is an exceptional opportunity to join a forward-thinking organization and make a significant impact on global health, working on cutting-edge therapies. Your expertise will be crucial in bringing life-changing treatments to patients worldwide. Embrace the future of pharmaceutical research in this exciting remote role.
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Clinical Research Associate I

London, London Russell Tobin

Posted today

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Job Description

contract
Job title: Clinical Project Associate I Location: London Contract duration: 12 months Client: Pharmaceutical Job Purpose: The Project Associate (PA) supports the planning and execution of multiple clinical development initiatives. Working closely with Clinical Development colleagues and cross-functional stakeholders, the PA drives operational efficiency and contributes to successful project delivery. The role ensures project activities are well-organized, deadlines are met, and communication flows effectively. Major Activities: • Project Planning, Coordination and Execution: Develop and maintain detailed project timelines, and contribute to content of key deliverables. Ensure all aspects of the project are organized and tracked effectively. Monitor completion status of deliverables, flag issues and opportunities, and escalate as needed. Ensure team is working in alignment with project objectives. Maintain project dashboards and support reporting for governance reviews. • Documentation Management: Maintain and manage project documents, reports, and meeting agendas/minutes, ensuring that all records are accurate and accessible. • Meeting Preparation & Facilitation: Schedule, prepare, and co-facilitate project meetings and workshops, ensuring adherence to meeting excellence standards (agenda, minutes, action items) • Communication: Act as a liaison between project teams and stakeholders, facilitating seamless information flow and collaboration. • Content creation: Creation of structured content in PowerPoint to support project needs and communication with project teams and stakeholders. • Quality Assurance: Monitor project deliverables to ensure they meet predefined quality standards. Contribute to continuous improvement initiatives and process optimization. • Risk Management: Identify potential risks in project execution and collaborate with the team to develop strategies to mitigate these risks. • Data Analysis: Analyze project-related data to extract insights that support informed decision-making. Contribute to benchmarking and background research on regulatory landscapes and industry practices. Primary focus will be supporting the Protocol Design Excellence (PDE) team within the Clinical Science group. Education and/or professional experience: • Bachelor’s degree in life sciences, public health, or a related field. Languages: • Fluent English (oral and written) Experience / Professional Requirements: • 2-3 years of experience in clinical research, project coordination or consultancy. • Understanding of Drug Development processes and familiarity with clinical trial processes and regulatory frameworks • Strong organisational, project management and communication skills. • Proficiency in Microsoft Office and project management tools. • Delivery focus; reliable and respond promptly to requests • Ability to multi-task and prioritize • Strong attention to detail and highly organized • Successful relationship builder and communicator • Ability to work independently and collaboratively in a fast-paced environment. • Desirable: Experience with AI tools in clinical development
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Clinical Research Associate I

London, London Russell Tobin

Posted today

Job Viewed

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Job Description

contract
Job title: Clinical Project Associate I Location: London Contract duration: 12 months Client: Pharmaceutical Job Purpose: The Project Associate (PA) supports the planning and execution of multiple clinical development initiatives. Working closely with Clinical Development colleagues and cross-functional stakeholders, the PA drives operational efficiency and contributes to successful project delivery. The role ensures project activities are well-organized, deadlines are met, and communication flows effectively. Major Activities: • Project Planning, Coordination and Execution: Develop and maintain detailed project timelines, and contribute to content of key deliverables. Ensure all aspects of the project are organized and tracked effectively. Monitor completion status of deliverables, flag issues and opportunities, and escalate as needed. Ensure team is working in alignment with project objectives. Maintain project dashboards and support reporting for governance reviews. • Documentation Management: Maintain and manage project documents, reports, and meeting agendas/minutes, ensuring that all records are accurate and accessible. • Meeting Preparation & Facilitation: Schedule, prepare, and co-facilitate project meetings and workshops, ensuring adherence to meeting excellence standards (agenda, minutes, action items) • Communication: Act as a liaison between project teams and stakeholders, facilitating seamless information flow and collaboration. • Content creation: Creation of structured content in PowerPoint to support project needs and communication with project teams and stakeholders. • Quality Assurance: Monitor project deliverables to ensure they meet predefined quality standards. Contribute to continuous improvement initiatives and process optimization. • Risk Management: Identify potential risks in project execution and collaborate with the team to develop strategies to mitigate these risks. • Data Analysis: Analyze project-related data to extract insights that support informed decision-making. Contribute to benchmarking and background research on regulatory landscapes and industry practices. Primary focus will be supporting the Protocol Design Excellence (PDE) team within the Clinical Science group. Education and/or professional experience: • Bachelor’s degree in life sciences, public health, or a related field. Languages: • Fluent English (oral and written) Experience / Professional Requirements: • 2-3 years of experience in clinical research, project coordination or consultancy. • Understanding of Drug Development processes and familiarity with clinical trial processes and regulatory frameworks • Strong organisational, project management and communication skills. • Proficiency in Microsoft Office and project management tools. • Delivery focus; reliable and respond promptly to requests • Ability to multi-task and prioritize • Strong attention to detail and highly organized • Successful relationship builder and communicator • Ability to work independently and collaboratively in a fast-paced environment. • Desirable: Experience with AI tools in clinical development
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate I

London, London Russell Tobin

Posted today

Job Viewed

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Job Description

Job title: Clinical Project Associate I

Location: London

Contract duration: 12 months

Client: Pharmaceutical


Job Purpose:

The Project Associate (PA) supports the planning and execution of multiple clinical development initiatives. Working closely with Clinical Development colleagues and cross-functional stakeholders, the PA drives operational efficiency and contributes to successful project delivery. The role ensures project activities are well-organized, deadlines are met, and communication flows effectively.


Major Activities:

Project Planning, Coordination and Execution: Develop and maintain detailed project timelines, and contribute to content of key deliverables. Ensure all aspects of the project are organized and tracked effectively. Monitor completion status of deliverables, flag issues and opportunities, and escalate as needed. Ensure team is working in alignment with project objectives. Maintain project dashboards and support reporting for governance reviews.

Documentation Management: Maintain and manage project documents, reports, and meeting agendas/minutes, ensuring that all records are accurate and accessible.

Meeting Preparation & Facilitation: Schedule, prepare, and co-facilitate project meetings and workshops, ensuring adherence to meeting excellence standards (agenda, minutes, action items)

Communication: Act as a liaison between project teams and stakeholders, facilitating seamless information flow and collaboration.

Content creation: Creation of structured content in PowerPoint to support project needs and communication with project teams and stakeholders.

Quality Assurance: Monitor project deliverables to ensure they meet predefined quality standards. Contribute to continuous improvement initiatives and process optimization.

Risk Management: Identify potential risks in project execution and collaborate with the team to develop strategies to mitigate these risks.

Data Analysis: Analyze project-related data to extract insights that support informed decision-making. Contribute to benchmarking and background research on regulatory landscapes and industry practices.


Primary focus will be supporting the Protocol Design Excellence (PDE) team within the Clinical Science group.


Education and/or professional experience:

• Bachelor’s degree in life sciences, public health, or a related field.


Languages:

• Fluent English (oral and written)


Experience / Professional Requirements:

• 2-3 years of experience in clinical research, project coordination or consultancy.

• Understanding of Drug Development processes and familiarity with clinical trial processes and regulatory frameworks

• Strong organisational, project management and communication skills.

• Proficiency in Microsoft Office and project management tools.

• Delivery focus; reliable and respond promptly to requests

• Ability to multi-task and prioritize

• Strong attention to detail and highly organized

• Successful relationship builder and communicator

• Ability to work independently and collaboratively in a fast-paced environment.

• Desirable: Experience with AI tools in clinical development

This advertiser has chosen not to accept applicants from your region.

Senior Clinical Research Physician

London, London Park Street People

Posted 7 days ago

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Job Description

Our client, an international clinical research organisation (CRO) is currently looking for a Senior Clinical Research Physician to join their team at their state of the art site in London.


As a Senior Clinical Research Physician, you will spearhead early stage clinical trials, manage study protocols and ensure ethical conduct and compliance at all stages. You will collaborate with an expert sponsor team and contribute to ground-breaking projects that advance healthcare and improve patient outcomes.


You will be driven to enhance patient safety, improve quality systems and ensure the data produced for the development of individual drugs is of the highest standard.


This role will offer tremendous scope for leadership and personal development. With this site being relatively new, this person will have the remit to grow and nurture a clinical research team around them as well as having significant involvement and influence with their sponsors.


The client is happy to consider candidates who are able to relocate from within the UK but sponsorship would unfortunately not be available.


Key Responsibilities

  • Provide medical direction, oversee protocol compliance and ensure participant safety throughout clinical trials.
  • Evaluate and interpret clinical data, performing necessary assessments to maintain data accuracy and integrity.
  • Collaborate on scientific feasibility for new inquiries, assisting sponsors and guiding clinical operations teams as needed.
  • Ensure adherence to regulatory requirements and Good Clinical Practice standards, maintaining rigorous documentation and participant confidentiality.


Requirements

  • A medical degree (MD) - essential
  • Full and current GMC registration - essential.
  • Strong background in clinical research / clinical trials.
  • Proven experience as a Principal Investigator or in a similar leadership role.
  • Strong knowledge of regulatory guidelines.
  • Excellent organisational, communication and analytical skills.


Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.

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Senior Clinical Research Physician

London, London Barrington James

Posted today

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Job Description

Our client, a global CRO, is seeking a Senior Clinical Research Physician to join their team.


In this role, you will lead early-stage clinical trials, oversee study protocols, and ensure ethical conduct and compliance throughout each study. You will work closely with experienced sponsor teams and contribute to innovative projects aimed at advancing healthcare and improving patient outcomes.


You will play a pivotal role in maintaining patient safety, enhancing quality systems, and ensuring that the clinical data generated meets the highest standards. This position offers significant opportunities for leadership and career development, including the chance to build and mentor a clinical research team and influence sponsor interactions. A strong focus on patient recruitment is critical, balancing trial integrity and safety while consistently achieving enrollment targets, including patient diversity goals.


Key Responsibilities

  • Provide strategic medical oversight for clinical trials, ensuring protocols are followed and participant safety is prioritized.
  • Critically evaluate and interpret trial data to uphold accuracy, quality, and scientific integrity.
  • Support study design and feasibility assessments, offering guidance to clinical operations and investigative teams.
  • Ensure all trials meet regulatory standards and Good Clinical Practice (GCP), maintaining meticulous documentation and confidentiality.


Requirements

  • Qualified medical doctor (MD) with full GMC registration and active licence to practise.
  • Broad experience in designing, managing, and delivering clinical trials, including work with CROs.
  • Established track record as a Principal Investigator or in senior clinical leadership roles.
  • Thorough knowledge of UK regulatory requirements and adherence to Good Clinical Practice (GCP).
  • Highly organized and analytical, with strong communication skills and proven ability to oversee complex, multi-site studies.
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About the latest Pharmacovigilance Jobs in London !

Senior Clinical Research Physician

London, London Barrington James

Posted today

Job Viewed

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Job Description

Our client, a global CRO, is seeking a Senior Clinical Research Physician to join their team. In this role, you will lead early-stage clinical trials, oversee study protocols, and ensure ethical conduct and compliance throughout each study. You will work closely with experienced sponsor teams and contribute to innovative projects aimed at advancing healthcare and improving patient outcomes. You will play a pivotal role in maintaining patient safety, enhancing quality systems, and ensuring that the clinical data generated meets the highest standards. This position offers significant opportunities for leadership and career development, including the chance to build and mentor a clinical research team and influence sponsor interactions. A strong focus on patient recruitment is critical, balancing trial integrity and safety while consistently achieving enrollment targets, including patient diversity goals. Key Responsibilities Provide strategic medical oversight for clinical trials, ensuring protocols are followed and participant safety is prioritized. Critically evaluate and interpret trial data to uphold accuracy, quality, and scientific integrity. Support study design and feasibility assessments, offering guidance to clinical operations and investigative teams. Ensure all trials meet regulatory standards and Good Clinical Practice (GCP), maintaining meticulous documentation and confidentiality. Requirements Qualified medical doctor (MD) with full GMC registration and active licence to practise. Broad experience in designing, managing, and delivering clinical trials, including work with CROs. Established track record as a Principal Investigator or in senior clinical leadership roles. Thorough knowledge of UK regulatory requirements and adherence to Good Clinical Practice (GCP). Highly organized and analytical, with strong communication skills and proven ability to oversee complex, multi-site studies.
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Senior Clinical Research Associate

SW1A 0AA London, London £65000 Annually WhatJobs

Posted 1 day ago

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Job Description

full-time
Our client , a leading pharmaceutical innovator, is seeking a highly skilled and motivated Senior Clinical Research Associate (CRA) to join their dynamic team in London, England, UK . This pivotal role will involve overseeing and managing clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities. You will serve as the primary point of contact for clinical investigators and site staff, providing essential support and guidance.

Key responsibilities include developing and implementing clinical trial monitoring plans, conducting regular site visits (both in-person and remote), verifying the accuracy and completeness of source data, and ensuring the timely submission of essential documents. You will also be instrumental in identifying and resolving site-level issues, preparing and presenting monitoring reports, and ensuring that all trial-related activities are conducted ethically and in accordance with ethical principles and patient safety standards. Collaboration with cross-functional teams, including data management, biostatistics, and regulatory affairs, is crucial for the successful execution of trials. The ideal candidate will possess strong leadership qualities, excellent communication and interpersonal skills, and a meticulous attention to detail. A proven track record in managing multiple complex clinical trials simultaneously is essential. This role offers an exciting opportunity to contribute to groundbreaking medical advancements within a supportive and progressive work environment. We are looking for an individual with a deep understanding of the drug development process and a passion for improving patient outcomes.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline. Advanced degree preferred.
  • Minimum of 5 years of direct experience as a Clinical Research Associate in the pharmaceutical or biotech industry.
  • Comprehensive knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
  • Demonstrated experience in managing all phases of clinical trials.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely.
  • Strong analytical and problem-solving abilities.
  • Ability to travel as required for site visits and team meetings.
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Senior Clinical Research Associate

SW1A 0AA London, London £55000 Annually WhatJobs

Posted 14 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dedicated team based in London, England, UK . This critical role involves overseeing and managing clinical trials, ensuring compliance with regulatory standards and protocol requirements. You will be responsible for site selection, initiation, monitoring, and close-out activities, building strong relationships with investigators and site staff. The ideal candidate will have a deep understanding of Good Clinical Practice (GCP) guidelines and experience with various therapeutic areas. Your responsibilities will include conducting site visits to assess patient safety, data integrity, and overall trial progress. You will also be involved in preparing study documentation, managing investigational product, and ensuring timely data collection and query resolution. Excellent communication, organisational, and problem-solving skills are essential for this role, as is the ability to work independently and as part of a wider clinical operations team. A Bachelor's degree in a life science, nursing, or a related field is required. A Master's degree or equivalent experience is highly desirable. Significant prior experience as a CRA, with a proven track record of successful trial management, is mandatory. Experience in oncology, cardiology, or another relevant therapeutic area would be advantageous. The ability to travel extensively (up to 60%) for site visits is required. This is an excellent opportunity to contribute to the development of life-saving medicines within a respected pharmaceutical organisation.
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