Thermo Fisher Scientific

Sr Safety Reporting Specialist

Thermo Fisher Scientific  •  São Paulo, BR (Remote)  •  14 days ago
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Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as Senior Safety Reporting Specialist – To lead and oversee the preparation of complex safety reports, ensure compliance with international pharmacovigilance regulations, and drive continuous improvement in our reporting processes to safeguard patient health.

What You’ll Do

  • Receive, prepare and submit safety reports to applicable parties. Ensure that all reports are compliant with regulatory timelines and country legislation and monitor this on a regular basis.
  • Lead large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines.
  • Provide input and feedback to aid the development of program and departmental procedural documents.
  • Sharing ideas and suggestions with team members. Take an active role in the development and implementation of ideas and suggestions.
  • Liaise with relevant departments around safety reporting tasks and attends various meetings as required.
  • Provide input, feedback and guidance to other team members and mentors new starters.
  • Produce metrics and have some involvement in financial project.

Education and Experience

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
  • Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).

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.

Knowledge, Skills and Abilities:

  • Excellent knowledge of medical terminology
  • Excellent Microsoft Office skills and good understanding of database functionality
  • Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements
  • Good time management and multi-tasking skills
  • Strong attention to detail
  • Ability to influence at all levels of the organization
  • Ability to work well in a collaborative team environment
  • Demonstrated initiative and utilizes persuasion and negotiation skills
  • Excellent critical thinking and problem-solving abilities
  • Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities

Working Conditions and Environment:

  • Work is performed in an office/ laboratory and/or a clinical environment.
  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Exposure to electrical office equipment.
  • Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements

  • Ability to work in an upright and /or stationary position for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Frequent mobility required.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.

Thermo Fisher Scientific

About Thermo Fisher Scientific

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.thermofisher.com.

Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Waltham, MA
Year Founded
Unknown
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