Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries.
Post : Safety Reporting Specialist
Job Description
Join us as Safety Reporting Specialist – To manage and coordinate the production of regulatory and safety reports, ensure accurate and timely documentation of adverse events, and support compliance with global pharmacovigilance requirements
What You'll Do
• Receive, prepare and submit safety reports to applicable parties. Escalate to lead and/or line manager if any issues are encountered. Ensure reports are submitted in compliance with regulatory timelines and country legislation.
• Assist in producing metrics and alerts managers to any quality or timeline issues.
• Participate in project teams and may lead projects of small to moderate scope.
• Provide training and support for other team members.
• Perform administrative tasks such as filing and the maintenance of safety reporting systems and information.
• Liaise with various departments around safety reporting tasks and the setting up of client accounts.
• Participating in audits where required and performing testing activities as needed.
• Share ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
Candidate Profile
• 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 2+ years’).
Knowledge, Skills, Abilities
• Strong knowledge of medical terminology
• Good written and verbal communication skills
• Good Microsoft Word and Excel skills and solid understanding of safety database functionality
• Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines)
• Ability to juggle multiple tasks while still delivering high quality results
• Strong attention to detail and accuracy with orientation toward careful and meticulous work
• Possess the maturity to handle sensitive information and data effectively
• Ability to interact effectively with all levels of the organization
• Strong critical thinking and problem-solving skills
Additional Information
Experience : 0 to 2 years
Qualification : Bachelor's degree
Location : Remote, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Research
Job ID : R-01371264
End Date : 30th November 2026
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