21 Drug Safety jobs in the United Kingdom
Senior Drug Safety Physician
Posted 2 days ago
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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
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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
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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.
Senior Formulation Scientist - Drug Development
Posted 6 days ago
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Job Description
Responsibilities:
- Lead the design, development, and optimization of innovative drug formulations (e.g., oral solid dosage forms, injectables, topical applications) for various therapeutic areas.
- Conduct pre-formulation studies to understand drug-excipient compatibility, physicochemical properties, and stability.
- Develop and validate analytical methods for characterizing formulations and assessing drug release profiles.
- Oversee formulation scale-up activities, ensuring successful technology transfer from lab to pilot and manufacturing scales.
- Prepare comprehensive technical documentation, including formulation development reports, analytical method validation reports, and regulatory submission documents.
- Collaborate closely with cross-functional teams, including analytical chemistry, process development, quality assurance, and regulatory affairs.
- Troubleshoot formulation challenges and implement robust solutions to ensure product quality and performance.
- Stay abreast of the latest advancements in pharmaceutical formulation science, drug delivery technologies, and relevant regulatory guidelines.
- Mentor and guide junior scientists, fostering a culture of scientific excellence and continuous learning.
- Manage external contract research organizations (CROs) for specific formulation development activities, ensuring project timelines and deliverables are met.
- PhD or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
- Minimum of 7 years of hands-on experience in pharmaceutical formulation development, with a proven track record in bringing drug products from concept to clinical trial stages.
- In-depth knowledge of various drug delivery systems and formulation techniques.
- Proficiency in relevant analytical techniques (e.g., HPLC, GC, DSC, XRPD) for formulation characterization.
- Strong understanding of pharmaceutical manufacturing processes and GMP requirements.
- Experience with regulatory guidelines (e.g., ICH, FDA, EMA) pertaining to drug development.
- Excellent problem-solving skills, with a keen attention to detail and the ability to interpret complex data.
- Exceptional written and verbal communication skills, with the ability to effectively present scientific findings.
- Proven ability to work independently and manage multiple projects in a remote research environment.
- Experience with statistical analysis software and design of experiments (DoE) is advantageous.
Principal Formulation Scientist - Drug Development
Posted 16 days ago
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Job Description
Qualifications:
- Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field
- Minimum of 7 years of progressive experience in pharmaceutical formulation development
- Proven expertise in developing various dosage forms (e.g., oral solids, injectables, topical)
- Strong understanding of pre-formulation, excipient selection, and drug-excipient compatibility
- Hands-on experience with formulation characterization techniques (e.g., DSC, TGA, XRPD, dissolution)
- Experience with pilot-scale formulation manufacturing and technology transfer
- Knowledge of GMP guidelines and regulatory requirements for drug development
- Excellent problem-solving, analytical, and critical thinking skills
- Strong project management and organizational abilities
- Effective communication and interpersonal skills for cross-functional collaboration
- Ability to mentor junior scientists and contribute to scientific strategy
- Experience with specific therapeutic areas is a plus
Pharmaceutical Formulation Scientist - Drug Development
Posted 16 days ago
Job Viewed
Job Description
- Designing, developing, and optimizing oral solid dosage forms (tablets, capsules) and potentially other dosage forms.
- Conducting pre-formulation studies to understand the physicochemical properties of active pharmaceutical ingredients (APIs) and excipients.
- Evaluating and selecting appropriate excipients to achieve desired drug release profiles and stability.
- Utilizing various laboratory techniques for formulation preparation and characterization (e.g., particle size analysis, dissolution testing, differential scanning calorimetry).
- Developing and validating analytical methods for drug product testing.
- Conducting stability studies to assess the shelf-life and performance of formulations under various conditions.
- Troubleshooting formulation challenges and proposing innovative solutions.
- Collaborating with analytical development, process development, and regulatory affairs teams.
- Documenting experimental procedures, results, and reports in accordance with company standards and regulatory guidelines.
- Staying current with scientific literature and industry trends in pharmaceutical formulation and drug delivery.
Senior Formulation Scientist - Innovative Drug Development
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Design, develop, and optimize novel drug delivery systems and formulations for various routes of administration (e.g., oral, injectable, topical).
- Conduct pre-formulation studies, including API characterization, solubility enhancement, and stability assessment.
- Perform compatibility studies and develop analytical methods for drug substance and drug product characterization.
- Utilize a range of formulation technologies and equipment, including granulation, coating, lyophilization, and sterile manufacturing processes.
- Execute experiments meticulously, document all findings accurately in laboratory notebooks and reports, and present results to project teams and management.
- Troubleshoot formulation challenges and propose innovative solutions.
- Collaborate closely with analytical chemists, process engineers, and clinical development teams to ensure successful project progression.
- Stay abreast of the latest scientific literature, regulatory guidelines, and industry trends in pharmaceutical formulation.
- Contribute to the preparation of regulatory submission documents (e.g., IND, NDA).
- PhD or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
- Minimum of 5 years of relevant experience in pharmaceutical formulation development, preferably within an R&D setting.
- Proven track record in developing various dosage forms, with a strong understanding of formulation science principles.
- Hands-on experience with laboratory equipment for formulation development and characterization.
- Proficiency in relevant analytical techniques (e.g., HPLC, GC, DSC, TGA, XRPD).
- Excellent understanding of Good Manufacturing Practice (GMP) and regulatory requirements.
- Strong problem-solving skills, attention to detail, and ability to work independently and as part of a team.
- Effective communication and interpersonal skills.
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Principal Clinical Research Scientist - Oncology Drug Development
Posted 6 days ago
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Job Description
Responsibilities:
- Lead the scientific strategy and design of Phase I-III clinical trials for novel oncology therapeutics.
- Oversee the development of clinical protocols, investigator brochures, and other essential study documents.
- Provide scientific and clinical expertise to cross-functional teams, including clinical operations, data management, regulatory affairs, and biomarker development.
- Analyze and interpret complex clinical trial data, translating findings into strategic recommendations for drug development.
- Prepare high-quality scientific publications, abstracts, and presentations for key medical conferences and journals.
- Engage with key opinion leaders (KOLs) in oncology to gather insights and foster collaboration.
- Contribute to regulatory submissions (e.g., IND, NDA) by preparing relevant clinical sections.
- Stay abreast of the latest advancements in oncology research, emerging therapeutic modalities, and competitive landscape.
- Mentor and guide junior scientists and clinical development professionals.
- Ensure all clinical research activities comply with GCP, regulatory guidelines, and company policies.
- Ph.D. or M.D. in a relevant life sciences discipline (e.g., Oncology, Immunology, Molecular Biology).
- Minimum of 10 years of experience in clinical drug development, with a strong focus on oncology.
- Demonstrated success in designing and leading complex clinical trials.
- Expertise in cancer biology, tumor microenvironment, and current therapeutic strategies.
- In-depth knowledge of GCP, regulatory requirements, and clinical trial methodologies.
- Proven ability to analyze and interpret clinical data effectively.
- Excellent scientific writing and communication skills, with a track record of publications and presentations.
- Strong leadership capabilities and experience working in a matrixed environment.
- Ability to travel to Glasgow, Scotland, UK as required for key meetings and site visits.
- Experience with immuno-oncology and targeted therapies is highly desirable.
Associate Director - Project Management - FSP - Drug Development exp

Posted 1 day ago
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Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**The PPD FSP Solution:**
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
_Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you're looking for a place where your work, in partnership with others, can have real impact-and where you're encouraged challenge yourself and contribute to breakthrough solutions , the_ **_A_** **_ssociate Director, Drug Development_** _role could be a great fit._
**Discover Impactful Work:**
The Associate Director within Drug Development will oversee high-level plans and progress for asset development, from pre-clinical stages to commercial launch. This role involves close collaboration with various stakeholders to ensure timely availability of documents and alignment with corporate strategy. Act as primary point of contact when concerning integrated cross-functional project planning and status. They closely collaborate with stakeholders who own, contribute to, and/or manage the project and the impact of decisions and changing circumstances. This to drive timely availability of documents as planned.
**A day in the Life:**
_Project Lead responsibilities:_
+ Serves as the primary contact between the sponsor and the organization at the project level.
+ On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
+ Drives and owns the overall delivery of the cross-functional project (time, cost, quality).
+ Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
+ Establishes, communicates and manages customer expectations to achieve optimal delivery during the project.
+ Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).
+ Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements
_Oversight Director responsibilities:_
+ Accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit.
+ Expertly navigates the need to dive in/dive out of situations while ensuring the Project Lead remains empowered .
+ Provokes critical thinking in Project Lead related to execution of delivery, financial negotiations and prioritization.
+ Provides insight into proposal strategy in prep for bid defense.
+ Works with Therapeutic Unit Head in development of business growth strategies.
+ Maintains awareness and engages as appropriate in the Con Mod process.
+ Communicates with People Manager(s) to support the development of the employee providing expertise and perspective related to client needs, indication and therapeutic knowledge.
_People Manager responsibilities:_
+ Accountable for the career development and performance management of a group of project delivery direct reports in line with The Core People Manager Expectations at the organization.
+ Partners with project team leadership and key stakeholders (i.e OD, SLT, BPL, DevOps, functional leadership) to ensure areas of development, training needs and coaching are aligned through routine and active engagement.
+ Provides coaching, soft skill and technical skill development to grow our Project Delivery talent.
+ Provides support/direction to direct report(s) with regards to knowledge of organization systems, processes and tools within Project Delivery.
+ Liaises with Resourcing Leads, TU Leadership and other key stakeholders to advocate for direct report(s), ensuring appropriate project assignment(s) and balance between career development and business needs.
+ Fosters collaboration and connections amongst peers.
+ Cultivates high quality relationships with each direct report to create a trusting environment.
+ Participates in Initiatives to foster talent development.
**Keys to Success:**
+ Advanced degree (Master or PhD) in a health-related discipline or equivalent experience.
+ At least 10 years of drug development experience across different disease areas.
+ At least 5 years of program management experience in the pharmaceutical or biotech industry.
**Knowledge, Skills, Abilities**
+ Strong leadership, communication, and collaborative skills.
+ Proven ability to mediate conflict and manage change.
+ Advanced project management skills and experience with MS Project.
+ PMP certification is an advantage.
+ Fluent in English (verbal and written).
+ Experience in Regulatory Affairs and/or Clinical Development is a plus.
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require travel. (Recruiter will provide more details.)
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Principal Scientist - Drug Discovery & Development
Posted 2 days ago
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Job Description
Key Responsibilities:
- Design, execute, and interpret complex experiments to drive drug discovery programmes forward.
- Lead and mentor a team of talented research scientists and technicians, fostering a culture of scientific excellence and collaboration.
- Develop and validate novel assays and technologies to support drug discovery efforts.
- Identify and evaluate promising therapeutic targets and lead compounds.
- Oversee preclinical studies, including in vitro and in vivo models, to assess compound efficacy and safety.
- Collaborate effectively with cross-functional teams, including chemistry, pharmacology, toxicology, and translational science.
- Author high-quality scientific reports, manuscripts, and patent applications.
- Present research findings at internal meetings and external scientific conferences.
- Manage external collaborations with academic institutions and contract research organizations (CROs).
- Contribute to strategic planning for the R&D pipeline and portfolio management.
- Ensure compliance with all relevant laboratory safety regulations and best practices.
- Stay abreast of the latest scientific advancements and competitive landscape in relevant therapeutic areas.
- Ph.D. in Pharmacology, Molecular Biology, Biochemistry, Immunology, or a related life science discipline.
- Minimum of 10 years of post-doctoral research experience in the pharmaceutical or biotechnology industry, with a strong focus on drug discovery.
- Demonstrated leadership experience in managing scientific teams and projects.
- Deep expertise in (Specific therapeutic area relevant to fictional company, e.g., oncology, infectious diseases, neuroscience) and associated drug discovery methodologies.
- Proficiency in a wide range of in vitro and in vivo experimental techniques.
- Proven ability to design and execute complex research strategies and troubleshoot effectively.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a track record of publications and presentations.
- Experience with biostatistics and data analysis software.
- Strong project management skills and the ability to manage multiple priorities.
- A passion for scientific innovation and a commitment to developing novel therapeutics.