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Thermo Fisher Scientific

Safety Writer II

Remote

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

About Thermo Fisher Scientific Inc.

Thermo Fisher Scientific Inc. is a global leader in the life science sector, providing world-class solutions to pharmaceutical companies, biotech companies, and Clinical Research Organizations (CROs). As the trusted partner of some of the most innovative big pharma and biotech companies, we offer exceptional opportunities for experienced Safety Writers to work on exciting projects across a wide range of therapeutic areas.

Job Description
As a Safety Writer at Thermo Fisher Scientific, you will play a crucial role in ensuring the flawless delivery of scientific and medical writing services. You will thrive in project teams, delivering outstanding levels of customer service and collaborating with clients to successfully conduct projects. Your responsibilities will include:

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  • Understanding, interpreting, analyzing, and presenting complex data
  • Writing concise and clear reports and documents
  • Managing multiple reports simultaneously and prioritizing work to meet strict timelines
  • Facilitating meetings and managing the review and comment resolution stages of document preparatio
  • Interacting directly with clients and providing exceptional customer service

Job Requirements

To qualify for this position, you must possess the following qualifications:

  • Bachelor's or higher scientific degree with 2 or more years of experience that aligns with the expectations of the role
  • Excellent written and verbal English interpersonal skills
  • Advanced knowledge of Microsoft Office package
  • Task-based project management experience and experience with client interaction
  • Good understanding and knowledge of aggregate safety report writing guidelines, clinical trial, and post-marketing pharmacovigilance
  • Experience authoring device aggregate safety reports or clinical evaluation reports is preferable

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

In addition, you must have a minimum of two years' experience in authoring two or more of the following report/document types for medicinal
products:

  • DSURs (Development Safety Update Reports)
  • PBRERs / PSURs (Periodic Benefit Risk Evaluation Reports / Periodic Safety Update Reports)
  • PA(D)ERs (Periodic Adverse [Drug] Experience Reports)
  • RMPs (Risk Management Plans)

Our Offer

At Thermo Fisher Scientific, we offer a positive and supportive working environment within one of the most engaged teams in the industry. We recognize our employees as the cornerstone of our success and provide opportunities for personal and professional growth. In addition, we offer a driven remuneration package and corporate training.

To apply for this position, please submit your CV in English through our website.

Please note that only short-listed candidates will be contacted.

Thermo Fisher Scientific is an equal opportunities employer.

Job ID: ThermoFisher-R-01288700
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program