Safety Specialist

2 tygodni temu


Warszawa, Mazovia, Polska Precision for Medicine Pełny etat

Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Due to our continued growth we are seeking a Safety Specialist who will be responsible forInterfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.

Essential functions of the job include but are not limited to:

  • Participate in the assessment and set-up of a safety database to capture SAE data.
  • Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
  • QC of documents and safety reports.
  • Preparation and/or review of project-specific safety reporting plans and medical coding plans.
  • Preparation and/or review of safety training materials.
  • Provide safety training and oversight for consultants, contractors and/or staff.
  • Review and/or draft standard operating procedures and work instructions.
  • Assist clients and/or other departmental staff with safety-related reviews and other services.
  • Other duties as assigned.

Qualifications:

Minimum Required:

  • Life Sciences Degree or equivalent
  • Minimum 3 years Clinical Trials Safety with Case Processing experience
  • Oncology experience is essential
  • Experience of managing multiple projects at one time
  • Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
  • Working knowledge of MedDRA and WHODrug
  • Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.

Preferred:

  • Nursing or pharmacy degree preferred
  • Clinical trial safety experience

#J-18808-Ljbffr

  • Warszawa, Mazovia, Polska Wolt Pełny etat

    The Health and Safety team at our company prioritizes the well-being of our employees and maintaining top safety standards in work environments across Poland. We are dedicated to developing and implementing robust health and safety policies, complying with regulations, and fostering a culture of safety and prevention. We are looking for a committed Health...


  • Warszawa, Mazovia, Polska Wolt Pełny etat

    The Health and Safety team at our company is committed to ensuring the well-being of our employees and maintaining the highest standards of safety in our work environments across Poland. We focus on developing and implementing robust health and safety policies that not only comply with local regulations but also promote a culture of safety and prevention. We...


  • Warszawa, Mazovia, Polska MSA, The Safety Company Pełny etat

    OverviewAre you someone who is passionate, motivated, and driven to make a difference? If so, MSA Safety is the perfect fit for your career. At MSA, SAFETY is who we are AND it is what we do. We are a purpose-driven company committed to deploying innovation and technology to deliver on our Mission to help protect people and assets all around the world. We...


  • Warszawa, Mazovia, Polska BOEING Pełny etat

    DescriptionQualifications:The Role: Boeing Poland is looking for an Occupational Health and Safety Officer (OHS), to be based in Gdansk supporting local operations and other work across Poland. This position will compliment the growing Environmental, Health & Safety (EHS) function across Europe and be part of an international EHS team. The successful...


  • Warszawa, Mazovia, Polska MSA, The Safety Company Pełny etat

    OverviewAre you someone who is passionate, motivated, and driven to make a difference? If so, MSA Safety is the perfect fit for your career. At MSA, SAFETY is who we are AND it is what we do. We are a purpose-driven company committed to deploying innovation and technology to deliver on our Mission to help protect people and assets all around the world. We...

  • EHS Specialist

    2 tygodni temu


    Warszawa, Mazovia, Polska Amazon Pełny etat

    Amazon EHS Specialist Jacksonville , Florida Apply Now One focus area of the Amazon Workplace Health & Safety (WHS) mission is to provide tools, resources, and environments that support safe, efficient, healthy behaviors and encourage employees to proactively manage their health and wellbeing. To support this focus area, Amazon is seeking a full-time WHS...


  • Warszawa, Mazovia, Polska MSA Safety Sp. z o.o. Pełny etat

    technologies-expected :SAPMicrosoft Exceltechnologies-optional :about-project :Data Analytics Expert will be responsible for providing high quality data analytics support, creating new tools and facilitate new Data Analytics technology. This role will be a primary contact for Commercial/Finance Leaders, Team Leaders & cross functional leadership. Within the...


  • Warszawa, Mazovia, Polska ZF Friedrichshafen AG Pełny etat

    Are you ready to make an impact? ZF is looking for talented individuals to join our team. As a FutureStarter, you'll have the opportunity to shape the future of mobility. Join us and be part of something extraordinary Product Packaging Specialist Country/Region: PL Location: Warszawa, MZ, PL, Main Responsibilities: Develop and improve cost driver tree....


  • Warszawa, Mazovia, Polska Danone Pełny etat

    Short Introduction and Job DescriptionAre you passionate about digital innovation and project management? Do you enjoy working in a fast-paced environment where you can explore, experiment, and suggest state-of-the-art solutions? If so, we have a fantastic opportunity for you.As a Digital Projects Specialist, your main focus will be on overseeing scoping,...


  • Warszawa, Mazovia, Polska ZF Group Pełny etat

    Req ID 68176 Warsaw, Poland Main Responsibilities:Develop and improve cost driver tree. Implement cost savings initiatives related to packaging materials, labor, efficiency, transportation and storage. Change management and project management leadership for global processes and packaging data tools. Analyze, develop and collaborate on data management...


  • Warszawa, Mazovia, Polska ZF Group Pełny etat

    Req ID 68176 Warsaw, Poland Main Responsibilities:Develop and improve cost driver tree. Implement cost savings initiatives related to packaging materials, labor, efficiency, transportation and storage. Change management and project management leadership for global processes and packaging data tools. Analyze, develop and collaborate on data management...


  • Warszawa, Mazovia, Polska ZF Group Pełny etat

    Req ID 68176 Warsaw, Poland Main Responsibilities:Develop and improve cost driver tree. Implement cost savings initiatives related to packaging materials, labor, efficiency, transportation and storage. Change management and project management leadership for global processes and packaging data tools. Analyze, develop and collaborate on data management...

  • Warehouse Specialist

    2 tygodni temu


    Warszawa, Mazovia, Polska Amentum Pełny etat

    Amentum Warehouse Specialist Jacksonville , Florida Apply Now The Warehouse Specialist performs a variety of warehousing duties that require an understanding of the establishments storage plan. Note: Exclude workers whose primary duties involve shipping and receiving work (see Shipping/Receiving Clerk), order filling (see Order Filler), or operating...

  • Senior M365 Specialist @

    2 tygodni temu


    Warszawa, Mazovia, Polska Simon - Kucher Core Business Services Pełny etat

    Senior M365 Specialist @ Simon - Kucher Core Business Services Warsaw, Masovian Voivodeship Senior M365 Specialist @ Simon - Kucher Core Business Services Warszawa Warsaw, Masovian Voivodeship, Polska Long-term employment based on an employment contractPrivate medical insurance in the highest package fully paid by the employerMultisport card fully financed...

  • Procurement Specialist

    4 tygodni temu


    Warszawa, Mazovia, Polska NES Fircroft Pełny etat

    Position: Procurement Specialist Company: International Energy Client Location: Not specified Your main role will be to work closely with a diverse team to create and execute procurement strategies both locally and globally for the Renewable Energy department. Responsibilities: Lead the sourcing process from start to finish, including analysis,...

  • Procurement Specialist

    1 miesiąc temu


    Warszawa, Mazovia, Polska NES Fircroft Pełny etat

    Position: Procurement Specialist Company: International Energy Client Location: Not specified Your main role will be to work closely with a diverse team to create and execute procurement strategies both locally and globally for the Renewable Energy department. Responsibilities: Lead the sourcing process from start to finish, including analysis,...


  • Warszawa, Mazovia, Polska Nonprofit Center of Northeast Florida Pełny etat

    The Match Support Specialist is primarily responsible for developing, implementing, and monitoring a caseload with a specific number of served matches by the end of each school year (served number outlined annually based on funding levels and sources) in each of the various site-based modelsincluding, Traditional School Based, Beyond School Walls (BSW), High...

  • Procurement Specialist

    2 tygodni temu


    Warszawa, Mazovia, Polska NES Fircroft Ltd Pełny etat

    For our international energy client, we are recruiting an experienced Procurement Specialist for the Renewable energy department.Your key responsibility will be to lead and collaborate with a cross-functional team to develop and implement procurement strategies locally and globally.Responsibilities:Oversee the entire sourcing process, including demand and...

  • Procurement Specialist

    2 tygodni temu


    Warszawa, Mazovia, Polska NES Fircroft Pełny etat

    For our international energy client, we are recruiting an experienced Procurement Specialist for the Renewable energy department.Your key responsibility will be to lead and collaborate with a cross-functional team to develop and implement procurement strategies locally and globally.Responsibilities:Oversee the entire sourcing process, including demand and...

  • EHS Specialist

    2 tygodni temu


    Warszawa, Mazovia, Polska JTI Pełny etat

    JTI, Japan Tobacco International, operating in 130 countries, continuously innovates to offer consumers a wide range of superior products. Our commitment goes beyond business, focusing on our employees' growth and potential. We strongly believe that by empowering them to be themselves and providing opportunities for development, remarkable achievements can...