5 Drug Safety Associate jobs in the United Kingdom

Senior Drug Safety Scientist

SW1A 0AA London, London £70000 Annually WhatJobs

Posted 1 day ago

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full-time
Our client, a globally recognized pharmaceutical leader, is seeking a highly experienced Senior Drug Safety Scientist to join their Pharmacovigilance team. This pivotal role is entirely remote, offering the flexibility to work from home across the UK while contributing to the safety monitoring of critical medicines. You will be responsible for ensuring the robust safety surveillance of pharmaceutical products, from clinical development through to post-marketing, and safeguarding patient well-being.

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.
This is an exceptional opportunity for a seasoned professional to make a significant impact on patient safety from a fully remote location. You will be part of a highly respected global team committed to excellence in pharmacovigilance. The role is aligned with the strategic goals for the London, England, UK area, but is entirely remote.
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist - Drug Safety

BN1 2AA East Sussex, South East £55000 Annually WhatJobs

Posted 22 days ago

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full-time
Our client, a globally recognized pharmaceutical organization with a strong pipeline of innovative medicines, is seeking a dedicated Senior Regulatory Affairs Specialist with a focus on Drug Safety. This office-based role in Brighton, East Sussex, UK offers a vital opportunity to ensure product compliance and patient safety. You will be responsible for managing pharmacovigilance activities, submissions, and compliance with global regulatory requirements. The ideal candidate will possess in-depth knowledge of regulatory affairs, drug safety principles, and a meticulous approach to documentation and compliance. Key Responsibilities:
  • Manage and oversee regulatory submissions related to drug safety, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and periodic safety update reports (PSURs).
  • Ensure compliance with global pharmacovigilance regulations (e.g., GVP Modules, FDA regulations) and company policies.
  • Prepare, review, and submit safety-related regulatory documents to health authorities worldwide.
  • Liaise with global regulatory agencies to address queries and provide necessary information regarding drug safety.
  • Collaborate closely with internal departments, including Clinical Development, Medical Affairs, and Quality Assurance, to ensure integrated safety reporting and compliance.
  • Monitor regulatory changes and assess their impact on company products and processes.
  • Develop and maintain regulatory submission documentation and databases.
  • Contribute to the development and implementation of company SOPs related to regulatory affairs and drug safety.
  • Provide expert advice and guidance on regulatory requirements to cross-functional teams.
  • Participate in regulatory inspections and audits, ensuring preparedness and compliance.
  • Support post-marketing safety surveillance activities and submissions.
Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree or equivalent is highly preferred.
  • Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry, with a specialization in drug safety/pharmacovigilance.
  • Thorough understanding of global regulatory requirements for drug safety and GxP.
  • Proven experience in preparing and submitting safety-related regulatory documents.
  • Excellent knowledge of pharmacovigilance principles and reporting requirements.
  • Strong analytical, problem-solving, and organizational skills.
  • Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
  • Proficiency in regulatory information management systems and safety databases.
  • Ability to work independently, manage multiple priorities, and meet strict deadlines.
  • Attention to detail and a commitment to maintaining the highest standards of compliance.
  • Candidates must be based in or willing to relocate to the Brighton, East Sussex, UK area for this office-based position.
This is a critical role ensuring the safety and compliance of pharmaceutical products, based in the beautiful coastal city of Brighton, East Sussex, UK .
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Research Associate - Safety Pharmacology

Harrogate, Yorkshire and the Humber Labcorp

Posted 13 days ago

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Job Description

**Are you looking for a role with training and progression opportunities?**
**Do you want to be responsible for the collection of data within our Cardiovascular Safety Pharmacology group?**
**Are you analytical and have excellent attention to detail?**
As one of the world's premier Contract Research Organisations, Labcorp's mission is to help build a healthier and safer world by providing research services for a multitude of organizations.
We strive to make a difference to people's everyday lives by bringing essential products to the market and as a **Research Associate** at our site **Harrogate, North Yorkshire,** you will play an essential part in making this happen.
In this role you will be providing technical support along with acquiring and analysing data in compliance with appropriate SOPs, GLPs, Home Office Licence requirements and regulatory agency guidelines. You will also be required to set up and maintain equipment.
This is a great opportunity for someone with previous experience in this area or someone who has previously worked with animals in industry and is looking to progress their scientific career. Your time will be spent in the animal units and office.
**The main responsibilities will include:**
+ Recording and analysing electronic data
+ Adhering to strict timelines for on time delivery of data for the team
+ Assisting with preparation of laboratory equipment for the team
+ Checking the accuracy of the data collected and ensuring this is put into specified formats
**You will:**
+ Learn data collection and analysis
+ Demonstrate basic understanding of ECG and blood pressure waveforms
+ Learn to recognize typical ECG complexes, basic ECG rhythms, and typical abnormal rhythms
+ Following training as applicable, provide technical and scientific support for data acquisition and analysis of data in accordance with the study protocol, regulatory guidelines, SOPs and needs of study direction
+ Learn or have an understanding of legality of use of animals in research (PIL A) and ASPA as relevant to role
+ Hold or obtain a Home Office Licence Modules 1-3
+ Learn to follow and understand all department specific SOPs, processes and best practices relevant to role
+ Gain familiarity with protocol requirements and Project Licenses as relevant to role
+ Begin to develop ability to review and provide input on protocols, amendments and reports for all relevant study types.
+ Data checking to ensure compliance with SOPs, Good Laboratory Practice (GLP) and reporting of any deviations
+ Begin to develop ability to monitor critical phases of studies and reports problems to the study management team
+ Understands study schedules and assists in the inter-department scheduling of studies as assigned
**What Labcorp can offer you:**
+ A competitive salary together with a comprehensive benefits package including health cover and pension
+ Unsurpassed career development opportunities supported by exceptional people from across the globe with an energized purpose
+ Ability to work with a variety of different clients on wide ranging projects
+ A culture of CARE with access to well-being programs and various employee resource groups
**Education:**
+ Minimum A Levels in related science field. Associate degree in Laboratory Animal Technology, or Associate degree in Veterinary Technology or a relevant BTEC advantageous
+ Home Office licence is preferred
+ Experience may be substituted for education requirements
**Skills / Experience:**
+ Previous scientific work experience desirable along with data acquisition and analysis, preferably working to GLP
+ Strong team player
+ Able to quickly learn new tasks and methodologies
+ Proficient with computers and software programs, specifically ability to learn ones utilized for departmental data collection and analysis
If you are looking to work within a supportive team, where there are real opportunities to learn, develop and progress then we would like to hear from you!
**Labcorp is proud to be an Equal Opportunity Employer:**
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
**We encourage all to apply**
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site ( or contact us at Labcorp Accessibility. ( ) For more information about how we collect and store your personal data, please see our Privacy Statement ( .
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Associate Safety and CDM Consultant

London, London £60000 - £70000 Annually The Health and Safety Partnership Limited

Posted today

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Job Description

permanent

Associate Safety and CDM Consultant required to join a multi-disciplinary, professional services company that manage and deliver construction safety and business safety services to clients across the UK and internationally.

Based in London, you will join the team to deliver high quality services for government organisations, leading developers, national infrastructure and clients across broad ranging sectors.

Duties

You will work as technical leader and manager overseeing approximately 50 Health and Safety experts, with a team of c5 consultants.

Your duties will include expanding workload through bidding and proposal drafting, coordinating local resources, and overseeing infrastructure projects for both current and prospective clients.

You will be accountable for managing and delivering results for client accounts.

Your responsibilities will also encompass offering technical guidance and ensuring quality assurance for CDM roles and safety services within projects.

Qualifications

Ideally hold or be working towards CMIOSH status or equivalent

Ideally hold a degree or higher level qualification in a relevant Health and Safety or Construction subject

Experience in the following:

Significant experience working in a consultancy environment delivering construction and business assurance services.

Managing and developing junior team members.

Delivering CDM duties as both the Principal Designer and the Client

Delivering audits, inspections and management system reviews.

Assisting with bid proposals and project set up.

The company understand the importance of a work life balance so the hybrid working policy allows flexibility. The role will pay 60k - 70k plus benefits and support with training, development and promotion.

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

Associate Safety and CDM Consultant

EC1 London, London The Health and Safety Partnership Limited

Posted today

Job Viewed

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Job Description

full time

Associate Safety and CDM Consultant required to join a multi-disciplinary, professional services company that manage and deliver construction safety and business safety services to clients across the UK and internationally.

Based in London, you will join the team to deliver high quality services for government organisations, leading developers, national infrastructure and clients across broad ranging sectors.

Duties

You will work as technical leader and manager overseeing approximately 50 Health and Safety experts, with a team of c5 consultants.

Your duties will include expanding workload through bidding and proposal drafting, coordinating local resources, and overseeing infrastructure projects for both current and prospective clients.

You will be accountable for managing and delivering results for client accounts.

Your responsibilities will also encompass offering technical guidance and ensuring quality assurance for CDM roles and safety services within projects.

Qualifications

Ideally hold or be working towards CMIOSH status or equivalent

Ideally hold a degree or higher level qualification in a relevant Health and Safety or Construction subject

Experience in the following:

Significant experience working in a consultancy environment delivering construction and business assurance services.

Managing and developing junior team members.

Delivering CDM duties as both the Principal Designer and the Client

Delivering audits, inspections and management system reviews.

Assisting with bid proposals and project set up.

The company understand the importance of a work life balance so the hybrid working policy allows flexibility. The role will pay 60k - 70k plus benefits and support with training, development and promotion.

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