29 Drug Safety Associates jobs in the United Kingdom
Senior Drug Safety Physician
Posted 2 days ago
Job Viewed
Job Description
Key Responsibilities:
- Oversee and manage all aspects of drug safety surveillance for assigned products, including clinical trials and post-marketing surveillance.
- Conduct thorough medical assessments of adverse event reports, determining causality and clinical significance.
- Prepare and review aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Signal Detection Reports.
- Contribute to the development and review of Risk Management Plans (RMPs) and other safety-related regulatory documents.
- Collaborate with clinical development, regulatory affairs, and medical affairs teams to ensure timely and accurate communication of safety information.
- Participate in safety monitoring committees and provide medical expertise during product development.
- Develop and maintain safety databases and ensure compliance with global regulatory requirements.
- Provide medical input for investigator brochures, informed consent forms, and clinical study protocols.
- Stay current with pharmacovigilance regulations, guidelines, and best practices.
- Mentor junior medical safety professionals and contribute to the training of the wider pharmacovigilance team.
- Medical degree (MD or equivalent) with board certification in a relevant clinical specialty.
- Substantial experience (7+ years) in pharmacovigilance and drug safety within the pharmaceutical industry.
- In-depth knowledge of global regulatory requirements for pharmacovigilance (e.g., ICH guidelines, FDA, EMA regulations).
- Proven experience in assessing adverse events, performing signal detection, and authoring safety reports.
- Strong understanding of clinical trial methodology and drug development processes.
- Excellent medical judgment, analytical skills, and attention to detail.
- Exceptional written and verbal communication skills, with the ability to present complex medical information effectively.
- Ability to work effectively both independently and as part of a collaborative, multi-disciplinary team.
- Experience with safety databases and pharmacovigilance software is essential.
- Commitment to patient safety and ethical conduct.
Lead Drug Safety Physician
Posted 15 days ago
Job Viewed
Job Description
Responsibilities:
- Lead the medical assessment of safety data from various sources, including spontaneous reports, clinical trials, and literature.
- Oversee the signal detection and risk management processes for assigned products.
- Provide medical expertise for the preparation of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other regulatory documents.
- Collaborate with regulatory affairs, clinical development, and other internal departments on safety-related matters.
- Act as a medical point of contact for health authorities regarding drug safety issues.
- Contribute to the development and implementation of pharmacovigilance strategies and SOPs.
- Mentor and provide medical guidance to other members of the safety team.
- Participate in safety reviews of clinical trial protocols and investigator brochures.
- Ensure compliance with global regulatory requirements for pharmacovigilance.
Qualifications:
- Medical Doctor (MD) or equivalent medical degree.
- Extensive experience (8+ years) in pharmacovigilance, drug safety, or clinical development within the pharmaceutical industry.
- Strong understanding of regulatory requirements in major markets (e.g., FDA, EMA).
- Proven experience in signal detection, risk assessment, and benefit-risk evaluation.
- Excellent medical judgment and analytical skills.
- Exceptional communication, presentation, and interpersonal skills.
- Demonstrated leadership capabilities and experience managing complex projects.
- Ability to work autonomously and effectively in a remote, global team environment.
- Proficiency in pharmacovigilance databases and reporting systems.
- Board certification in a relevant medical specialty is a plus.
Senior Drug Safety Scientist
Posted 16 days ago
Job Viewed
Job Description
Responsibilities:
- Perform comprehensive case processing and medical assessment of adverse event reports, ensuring compliance with regulatory requirements and company procedures.
- Contribute to the preparation and maintenance of periodic safety update reports (PSURs), development safety update reports (DSURs), and risk management plans (RMPs).
- Conduct signal detection and evaluation activities, identifying potential safety concerns and recommending appropriate actions.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, on safety-related matters.
- Interpret safety data and provide expert input into clinical trial protocols, Investigator's Brochures, and informed consent forms.
- Serve as a subject matter expert on drug safety regulations and guidelines in various global markets.
- Contribute to the development and implementation of pharmacovigilance strategies and processes.
- Participate in regulatory authority inspections and internal audits.
- Mentor and provide guidance to junior safety scientists and case processing personnel.
- Stay current with evolving regulatory landscapes and scientific literature related to drug safety.
Qualifications:
- Medical degree (MD, DO, MBBS) or equivalent healthcare professional qualification (e.g., PhD in a relevant life science field with significant safety experience).
- Minimum of 6 years of direct experience in drug safety and pharmacovigilance within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA guidelines) and reporting requirements.
- Experience with safety databases (e.g., Argus, ARISg) and case processing.
- Proficiency in signal detection and management methodologies.
- Strong medical assessment and analytical skills, with the ability to critically evaluate safety data.
- Excellent written and verbal communication skills, with the ability to present complex information effectively.
- Proven ability to work independently and manage multiple priorities in a remote setting.
- Strong collaboration and interpersonal skills.
- Experience with risk management planning and execution.
Clinical Trials Prosthetist
Posted 4 days ago
Job Viewed
Job Description
Do you want to put your clinical expertise to work in a whole new way?
Help shape the future of Blatchford products by using your clinical insight to help bring amazing ideas to reality that truly make a difference.
Blatchford is a multi-award winning, global manufacturer of some of the world’s most advanced prosthetic technology, bespoke seating solutions and orthotic devices. Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users.
Through science, technology, and maintaining a clear focus on people, we make mobility possible.
We are driven by a clear purpose: to deliver superior clinical outcomes. We have a brand new, exciting opportunity for a Clinical Trials Prosthetist to strengthen our global clinical research team and ensure our pioneering technologies are validated with the highest standards of safety, ethics, and scientific rigor.
The role
As Clinical Trials Prosthetist , you will focus on prosthetic products, along with supporting other product/clinical areas. This is a flexible opportunity to share your expertise, influence product development, and help bring innovative mobility solutions to life.
Key duties:
- Providing clinical oversight for all participants in Blatchford-sponsored clinical trials across our varied products.
- Providing direct clinical input to our prosthetic R&D and Marketing advocates to maintain your clinical registration.
- Ensuring compliance with clinical trial protocols, Good Clinical Practice and regulatory requirements.
- Supporting trial design by contributing clinical expertise to protocol development, feasibility assessments, and outcome measures.
- Liaising with our clinical teams based in the UK and Norway and our global educators to ensure their ‘on the ground’ feedback is heard and incorporated when appropriate.
- Presenting our clinical findings at national and international conferences
- Serving as the clinical point of contact for investigators, study coordinators, regulatory authorities, and internal teams.
- Overseeing accurate clinical documentation and supporting the interpretation of trial data.
- Contributing to Blatchford’s mission of advancing mobility by ensuring our innovations are validated with robust clinical evidence.
What can we offer you?
As Clinical Trials Prosthetist, you will receive the following:
Benefits
- Highly competitive salary
- Flexible, hybrid working.
- 25 days holiday (rising with service)
- Option to purchase additional annual leave.
- Pension
- Death in service
- Discounted shopping and leisure activities
- Health cash plan
- Cycle to work scheme.
- A meaningful role where your work directly improves patients’ mobility and independence.
- A collaborative, international research environment at the forefront of medical technology.
- Opportunities for professional growth and development within a global innovation leader.
What are we looking for?
Key skills
- Qualified Prosthetist experience.
- Good level of clinical experience.
- Strong product knowledge in lower-limb prosthetics, including familiarity with microprocessor and mechanical prosthetic systems.
- Have experience of clinical trials or research.
- Good knowledge of ethics, and regulatory standards.
- Excellent communication and collaboration skills, with the ability to work across multidisciplinary and international teams.
- Passionate about advancing patient outcomes and bringing life-changing technologies to market.
If you feel like you meet the above criteria for this exciting Clinical Trials Prosthetist opportunity, then please apply now!
Clinical Trials Prosthetist
Posted today
Job Viewed
Job Description
Clinical Trials Manager
Posted 5 days ago
Job Viewed
Job Description
- Developing comprehensive clinical trial protocols and study plans.
- Identifying, selecting, and managing investigative sites and study personnel.
- Overseeing the day-to-day operations of clinical trials, including patient recruitment, data collection, and monitoring.
- Ensuring compliance with all applicable regulatory requirements (e.g., FDA, EMA, MHRA) and Good Clinical Practice (GCP).
- Managing clinical trial budgets and timelines effectively.
- Developing and maintaining strong relationships with investigators, study coordinators, and other stakeholders.
- Preparing and submitting study-related documents, including Investigator Brochures and Essential Documents.
- Risk assessment and mitigation planning for clinical trials.
- Managing vendors and external service providers involved in clinical trials.
- Contributing to the development and implementation of Standard Operating Procedures (SOPs) related to clinical trial management.
- Ensuring accurate and timely data management and reporting.
- Leading and motivating clinical research associates (CRAs) and other study team members.
- Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GCP, ICH guidelines, and regulatory submission processes.
- Proven experience in managing multiple clinical trials simultaneously.
- Strong project management skills with a demonstrated ability to manage complex projects.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in clinical trial management software and electronic data capture (EDC) systems.
- Ability to travel as required to investigative sites and meetings.
- Strong problem-solving abilities and attention to detail.
- Experience in (specific therapeutic area, e.g., oncology, cardiology) is a significant advantage.
Clinical Trials Prosthetist
Posted today
Job Viewed
Job Description
Do you want to put your clinical expertise to work in a whole new way?
Help shape the future of Blatchford products by using your clinical insight to help bring amazing ideas to reality that truly make a difference.
Blatchford is a multi-award winning, global manufacturer of some of the world’s most advanced prosthetic technology, bespoke seating solutions and orthotic devices. Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users.
Through science, technology, and maintaining a clear focus on people, we make mobility possible.
We are driven by a clear purpose: to deliver superior clinical outcomes. We have a brand new, exciting opportunity for a Clinical Trials Prosthetist to strengthen our global clinical research team and ensure our pioneering technologies are validated with the highest standards of safety, ethics, and scientific rigor.
The role
As Clinical Trials Prosthetist , you will focus on prosthetic products, along with supporting other product/clinical areas. This is a flexible opportunity to share your expertise, influence product development, and help bring innovative mobility solutions to life.
Key duties:
- Providing clinical oversight for all participants in Blatchford-sponsored clinical trials across our varied products.
- Providing direct clinical input to our prosthetic R&D and Marketing advocates to maintain your clinical registration.
- Ensuring compliance with clinical trial protocols, Good Clinical Practice and regulatory requirements.
- Supporting trial design by contributing clinical expertise to protocol development, feasibility assessments, and outcome measures.
- Liaising with our clinical teams based in the UK and Norway and our global educators to ensure their ‘on the ground’ feedback is heard and incorporated when appropriate.
- Presenting our clinical findings at national and international conferences
- Serving as the clinical point of contact for investigators, study coordinators, regulatory authorities, and internal teams.
- Overseeing accurate clinical documentation and supporting the interpretation of trial data.
- Contributing to Blatchford’s mission of advancing mobility by ensuring our innovations are validated with robust clinical evidence.
What can we offer you?
As Clinical Trials Prosthetist, you will receive the following:
Benefits
- Highly competitive salary
- Flexible, hybrid working.
- 25 days holiday (rising with service)
- Option to purchase additional annual leave.
- Pension
- Death in service
- Discounted shopping and leisure activities
- Health cash plan
- Cycle to work scheme.
- A meaningful role where your work directly improves patients’ mobility and independence.
- A collaborative, international research environment at the forefront of medical technology.
- Opportunities for professional growth and development within a global innovation leader.
What are we looking for?
Key skills
- Qualified Prosthetist experience.
- Good level of clinical experience.
- Strong product knowledge in lower-limb prosthetics, including familiarity with microprocessor and mechanical prosthetic systems.
- Have experience of clinical trials or research.
- Good knowledge of ethics, and regulatory standards.
- Excellent communication and collaboration skills, with the ability to work across multidisciplinary and international teams.
- Passionate about advancing patient outcomes and bringing life-changing technologies to market.
If you feel like you meet the above criteria for this exciting Clinical Trials Prosthetist opportunity, then please apply now!
Be The First To Know
About the latest Drug safety associates Jobs in United Kingdom !
Clinical Trials - Sales Lead
Posted today
Job Viewed
Job Description
Clinical Trials - Sales Lead
Posted 5 days ago
Job Viewed
Job Description
Who we are:
We are Vet-AI, and we are delivering the future of pet care and clinical research. While our flagship app, Joii Pet Care, makes pet care affordable and accessible for all pet owners, we are also at the forefront of digital veterinary trials. Our platform enables efficient and effective clinical research for veterinary medicine, leveraging the insights gained from Joii's extensive user base.
Our mission:
- To make pet care affordable and accessible for everyone.
- To improve the lives and wellbeing of everyone working within the veterinary industry.
- To advance veterinary medicine through digitally led trials, using Joii Pet Care to connect research sponsors with pet owner databases
Quite simply, we want vet care to be available to everyone, to ensure the people who are delivering it with us are as happy as they can be, and to drive innovation in animal health through our trials platform, all while keeping the spirit of Joii alive.
Role Summary:
As Clinical Trials - Sales Lead, you will take full ownership of the sales function for our Clinical Trials business line. You’ll be responsible for developing strategy, building a high-quality pipeline, and converting opportunities into long-term partnerships with pet food companies and other pet care businesses.
Working closely with leadership, you will design client solutions and ensure a seamless journey from first contact through to proposal and closure. This is a unique opportunity to shape and grow a key revenue stream in a scaling business.
Job Responsibilities:
- Define and implement a sales strategy for the Clinical Trials division.
- Own the end-to-end sales cycle: prospecting, lead generation, consultative solution design, proposal development, negotiation, and closing.
- Build strong relationships with decision-makers in the pet food and pet care industries.
- Maintain a healthy, well-documented sales pipeline with accurate forecasting and reporting.
- Collaborate with internal teams to design solutions that deliver real value for clients.
- Represent the company at industry events, conferences, and networking forums.
Essential:
- We are looking for someone ambitious, commercially minded, and excited about scaling a business in a dynamic sector.
- Proven track record in clinical trials sales, pet care, healthcare, or life sciences.
- Experience selling into pet food companies and the wider pet care sector.
- Demonstrated success in building and managing a sales pipeline.
- Strong consultative sales skills, with the ability to design and present compelling solutions.
- Experience working in a startup or scale-up environment, comfortable building processes and taking ownership.
- Excellent communication, influencing, and relationship management skills.
Desirable:
- Established a network within the pet food or pet care industries.
- Knowledge of clinical trial operations, regulatory frameworks, or R&D partnerships in pet health.
Our brand values:
Brave;
- We are not afraid to disrupt the status quo. Championing what’s right for pets and standing confidently behind our purpose. Even when it’s challenged.
- We have the courage and confidence to tackle things that nobody has done before.
- We may face hurdles, adversity, and the fear of failure but we have the conviction to keep going.
Boundless;
- We do not constrain ourselves to the expectations of traditional pet care; we’re young, bright and full of fresh ideas.
- We bring energy and pro-activity to everything we do. We’re problem solvers, with a ‘can do’ outlook.
- Our boundless attitude brings the joy.
Togetherness;
- We share an ‘in-it-together’ mindset. We’re one team; we don’t leave anyone to face problems alone when we can help.
- We champion empathy and compassion; caring about what our customers and our colleagues are going through. Going above and beyond when they need us.
- We strive for constant collaboration, no matter where we are in the world
What you’ll get:
We are a startup transitioning to a scale-up, so if you like a slow pace, we’re not the company for you. However, if you do like a supportive team, a fun culture, and the feeling of creating incredible work - you’ll fit right in! Some of the perks you’ll get with us are:
Fully remote (UK
Access to a co-working space budget
Private Medical Insurance & Group Life Assurance
Remote Clinical Trials Coordinator
Posted 6 days ago
Job Viewed
Job Description
Key Responsibilities:
- Coordinate all aspects of assigned clinical trials remotely, adhering to study protocols and Good Clinical Practice (GCP) guidelines.
- Assist in the preparation and submission of study-related documents, including Investigational New Drug (IND) applications and Institutional Review Board (IRB) submissions.
- Recruit, screen, and enroll eligible participants for clinical trials, conducting initial remote assessments and consultations.
- Schedule and manage participant appointments, ensuring adherence to the trial schedule and protocol requirements.
- Collect, manage, and maintain accurate study data in electronic data capture (EDC) systems.
- Monitor study progress, identify potential issues or deviations, and implement corrective actions as needed.
- Communicate effectively with investigators, study coordinators, and other site personnel to ensure smooth trial operations.
- Prepare and submit regulatory and progress reports as required.
- Ensure the proper storage and handling of investigational products and biological samples.
- Maintain all study-related documentation and files in a compliant and organized manner.
- Conduct remote monitoring visits to ensure protocol adherence and data integrity.
- Provide support and education to study participants regarding trial procedures and requirements.
- Bachelor's degree in a life science, nursing, or a related field; Master's degree preferred.
- Minimum of 3-5 years of experience in clinical research coordination or a similar role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proficiency with electronic data capture (EDC) systems and other clinical trial management software.
- Excellent organizational, time management, and multitasking abilities.
- Strong written and verbal communication skills, with the ability to communicate effectively with diverse stakeholders.
- Demonstrated ability to work independently and proactively in a remote setting.
- Detail-oriented with a commitment to data accuracy and integrity.
- Experience in specific therapeutic areas (e.g., oncology, cardiology) is a plus.
- Certification as a Clinical Research Professional (e.g., ACRP, SoCRA) is highly desirable.