Qureos Mentor

EPM Scientific

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 Senior Clinical Safety Scientist
 
 
 
 The Senior Clinical Safety Scientist is responsible for leading proactive safety surveillance activities for investigational medicinal products evaluated in interventional clinical studies. This role serves as a key point of contact for project teams and external partners on all safety-related matters and collaborates closely with Clinical Safety Physicians on scientific and medical safety aspects of clinical programs.
 
 
 
 Key Responsibilities
 
 
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 Support Clinical Safety Physicians with safety-related tasks across prescription (Rx) products in development, including global Phase I-IV and regional interventional studies.
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 Contribute to post-marketing safety activities following regulatory approval.
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 Conduct signal detection, validation, and evaluation activities as directed, and present safety observations or analyses in safety review meetings.
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 Contribute to the preparation of aggregate safety reports such as DSURs, PSURs, and PBRERs for investigational products.
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 Assist with regulatory dossier submissions, including Clinical Overviews, Clinical Evaluation Reports, and Summaries of Clinical Safety.
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 Provide input on updates to the Investigator's Brochure, particularly the Reference Safety Information.
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 Review safety sections of study protocols and informed consent forms (ICFs).
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 Review and update safety content in Clinical Study Reports and related publications.
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 Represent Clinical Safety in study team meetings and collaborate with internal and external stakeholders to ensure timely delivery of safety-related milestones.
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 Provide input into Safety Data Exchange Agreements and Study Safety Management Plans.
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 Contribute to the development and review of departmental quality documents, such as SOPs and working guidelines.
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Senior Safety Scientist

<div>
 
 
 R&amp;D Scientist
 
 
 
 Are you passionate about science and organization? We're looking for a
 
 hands-on scientist
 
 who can also
 
 drive project coordination
 
 across R&amp;D and analytical initiatives. This role blends technical expertise with leadership in planning and communication.
 
 
 
 What You'll Do
 
 
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 <li>
 Track and manage R&amp;D and analytical projects, ensuring timelines and priorities are met.
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 Maintain project dashboards and prepare concise progress updates for leadership.
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 Support formulation experiments, sample prep, and analytical testing (HPLC, dissolution, stability).
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 Collaborate with QA, Regulatory, and Operations to align deliverables.
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 Recommend process improvements and help implement standardized tools.
 
 
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 </ul>
 What We're Looking For
 
 
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 Education:
 
 Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
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 Experience:
 
 3-6 years in pharmaceutical R&amp;D, analytical chemistry, or formulation science.
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 Familiarity with HPLC and method development.
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 Strong organizational and communication skills.
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 Comfortable balancing lab work with coordination responsibilities.
 
 
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 Why Join Us
 
 
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 Competitive salary + comprehensive benefits.
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 Health, dental, vision coverage.
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 Retirement plan with company match.
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 Paid time off and holidays.
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 Collaborative, science-driven environment.
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R&D Scientist

Join EPM Scientific and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

EPM Scientific

ABOUT_COMPANY

Senior Safety Scientist

R&D Scientist