Thermofisher Scientific is hiring for Safety Reporting Specialist | Apply Now
Role :
Safety Reporting Specialist
Location :
WORK FROM HOME
JOB DESCRIPTION:
The Associate Safety Reporting Specialist helps with the receipt, submission, and ongoing tracking of expedited and periodic safety reports for the department’s projects. Provides support to management in generating project metrics when needed. Takes part in projects and programs that involve safety reporting.
Over the last 5 years, we have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, covering 2,700 clinical trials across 100+ countries.
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What you will do
- Any skills related to the role
- the selected Should have excellent English communication with a decent accent
- • Receive, prepare, and submit safety reports to the relevant parties, ensuring compliance with regulatory deadlines and national legislation.
• Keep track of all expedited and periodic safety report submissions, ensuring that evidence of submission is retained. Notify your lead and/or line manager of any quality or timeline concerns.
• Develop project management skills by supporting an assigned lead, and you may also lead small projects.
• Coordinate with relevant teams on safety reporting tasks and support the assigned lead as needed.
• Generate reports and ensure that repositories and systems are kept updated with current contact information. Provide ad hoc administrative support whenever needed.
• Ensure regulatory submission files and filing processes are prepared, set up, maintained, and archived in line with the organization’s WPDs or applicable client SOPs.
• Support the manager in compiling metrics.
Education Required:
• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’).
Any Graduation
Any stream
Fresher’s
Experienced also
skills
In certain instances, an equivalency made up of a suitable mix of relevant education and training
and/or experience that is directly related will be deemed adequate for a person to satisfy the
requirements for the position.Knowledge, Skills, and Abilities:
• Foundational understanding of medical terminology
• Solid written and verbal communication abilities
• Competence with Microsoft Office applications and a fundamental grasp of how safety databases function
• Basic familiarity with procedural documents and practical knowledge of global safety reporting requirements (including FDA regulations and guidelines)
• Solid organizational and time management abilities
• Keen attention to detail and accuracy, with a focus on careful and meticulous work
• Demonstrates the maturity to manage sensitive information and data effectively
• Capable of interacting effectively with every level of the organization
• Able to work effectively as part of a team
HOW TO APPLY :
• First, read through all of the job details on this page.
Scroll down and press the Apply Link button.
• To be redirected to the official website, click on the apply link.
• Fill the details with the information provided.
Before submitting the application, cross-check the information you’ve provided.
SALARY :
As pe the Company Norms
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