Clinical Safety Scientist

Clinical Safety Scientist

Dartford Temporary 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Monitor and evaluate safety profiles for HIV treatment products, ensuring compliance and risk management.
  • Company: Join a leading organisation focused on innovative healthcare solutions for HIV prevention and treatment.
  • Benefits: Enjoy fully remote work, flexible hours, and opportunities for professional growth.
  • Why this job: Make a real impact in global health while working in a supportive and dynamic environment.
  • Qualifications: Bachelor's degree in Biomedical or Health Care; strong writing and analytical skills required.
  • Other info: This is a 6-month contract role with potential for extension based on performance.

The predicted salary is between 36000 - 60000 £ per year.

Fully Remote Duration: 6 Months

To provide safety support and expertise with particular focus on medicines for the treatment and prevention of HIV. The key focus is on safety, evaluation and risk-management.

Day-to-day responsibility for monitoring and evaluating safety profiles for allocated products to ensure that optimal decisions are made at all stages of the product lifecycle, which may span late phase clinical development through to established post-marketing use. Depending on the individual product responsibility, the role will include conducting routine pharmacovigilance activities, signal detection/evaluation and authoring of key regulatory documents (e.g. DSURs, EU RMPs and PBRERs). Throughout delivery of the role, you will ensure that all safety documentation is accurate and available to meet global compliance and regulatory requirements.

Detailed responsibilities may include:

  • Authors or assists in the production of global Risk Management Plans for designated products, in consultation with senior colleagues
  • Contributing to Regulatory benefit-risk assessments
  • Assists in the update of investigator brochures.
  • Assist in routine signal detection process, literature review and, in partnership with safety physician, tools for individual case awareness for all products in area of responsibility.
  • Performs signal evaluation activities including analysis of safety data and production of accurate and fit for purpose evaluation documents with clear conclusions.
  • Assist in authoring periodic regulatory documents (PSURs [PBRERs], DSURs, licence renewal documentation) according to the agreed process and timelines

EDUCATION, KNOWLEDGE AND TECHNICAL EXPERIENCE

  • Bachelors, or above, degree in Biomedical or Health Care related speciality
  • Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
  • Competent medical/scientific writing skills
  • Sound computing skills
  • Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
  • Knowledge and experience of the principles of causality assessment and the evaluation of safety signals
  • Basic understanding of the HIV therapy area would be an advantage
  • Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology)
  • Basic knowledge of medical and drug terminology
  • Basic understanding of drug development process
  • Basic understanding of drug approval process in major countries

Clinical Safety Scientist employer: LanceSoft, Inc.

As a fully remote employer, we pride ourselves on fostering a flexible and inclusive work culture that prioritises employee well-being and professional growth. Our commitment to the development of innovative treatments for HIV not only provides meaningful work but also offers unique opportunities for career advancement through continuous learning and collaboration with industry experts. Join us to be part of a dedicated team where your contributions directly impact global health outcomes.
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Contact Detail:

LanceSoft, Inc. Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Clinical Safety Scientist

✨Tip Number 1

Familiarise yourself with the latest pharmacovigilance regulations and methodologies. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.

✨Tip Number 2

Network with professionals in the clinical safety and pharmacovigilance sectors. Engaging with industry experts can provide insights into the role and may even lead to referrals or recommendations.

✨Tip Number 3

Gain practical experience by volunteering for projects related to HIV treatment or safety evaluation. This hands-on experience can set you apart from other candidates and show your genuine interest in the field.

✨Tip Number 4

Prepare for potential interview questions by reviewing common scenarios in pharmacovigilance, especially those related to signal detection and risk management. Being well-prepared will boost your confidence and help you articulate your expertise effectively.

We think you need these skills to ace Clinical Safety Scientist

Pharmacovigilance Expertise
Risk Management Planning
Signal Detection and Evaluation
Medical Writing Skills
Data Analysis and Interpretation
Regulatory Compliance Knowledge
Knowledge of HIV Therapies
Scientific Literature Review
Communication Skills
Attention to Detail
Understanding of Drug Development Processes
Knowledge of Causality Assessment Principles
Familiarity with Regulatory Documents (e.g. DSURs, PBRERs)
Basic Statistical Knowledge
Computing Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in pharmacovigilance, safety evaluation, and medical writing. Emphasise any specific projects or roles related to HIV treatment and prevention.

Craft a Compelling Cover Letter: In your cover letter, express your passion for clinical safety and your understanding of the importance of risk management in drug development. Mention how your background aligns with the responsibilities outlined in the job description.

Highlight Relevant Skills: Clearly outline your competencies in scientific literature review, data analysis, and regulatory documentation. Use specific examples to demonstrate your proficiency in these areas, especially in relation to safety profiles and signal detection.

Showcase Continuous Learning: Mention any ongoing education or training related to pharmacovigilance or HIV therapy. This shows your commitment to staying updated in the field and enhances your application.

How to prepare for a job interview at LanceSoft, Inc.

✨Know Your Pharmacovigilance Regulations

Make sure you brush up on the relevant pharmacovigilance regulations and methodologies. Being able to discuss these confidently will show that you understand the compliance landscape and can navigate it effectively.

✨Demonstrate Your Medical Writing Skills

Prepare to showcase your medical and scientific writing abilities. Bring examples of your previous work, such as regulatory documents or safety evaluations, to demonstrate your competence in this area.

✨Familiarise Yourself with HIV Therapies

While a basic understanding is mentioned, going a step further by familiarising yourself with current HIV therapies and their safety profiles can set you apart. This knowledge will help you engage more deeply during discussions.

✨Prepare for Signal Detection Scenarios

Be ready to discuss your experience with signal detection processes. Think of specific examples where you've analysed safety data and produced evaluation documents, as this will highlight your practical skills in the role.

Clinical Safety Scientist
LanceSoft, Inc.
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  • Clinical Safety Scientist

    Dartford
    Temporary
    36000 - 60000 £ / year (est.)

    Application deadline: 2027-05-01

  • L

    LanceSoft, Inc.

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