Role at a glance
- Job function
-
Legal & Compliance Compliance & Regulatory Affairs
- Salary
- Not Disclosed
- Location
- Remote - Bulgaria
- Work arrangement
- Remote
- Employment
- Full-time
- Education
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
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Role Summary
The Senior Safety Reporting Specialist leads and oversees the preparation and submission of complex safety reports in support of international pharmacovigilance compliance. The role works across relevant departments and contributes to process improvement and patient safety through reporting oversight, project support, and team guidance.
What You'll Do
- Receive, prepare, and submit safety reports to applicable parties while monitoring regulatory timelines and country legislation.
- Lead large-scale projects and ensure safety reports are submitted according to agreed processes and regulatory timelines.
- Provide input and feedback for program and departmental procedural documents.
- Liaise with relevant departments and attend meetings related to safety reporting tasks.
- Provide guidance to team members and mentor new starters.
- Produce metrics and contribute to financial projects.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Knowledge of medical terminology, Microsoft Office, database functionality, procedural documents, and global safety reporting requirements; strong time management, attention to detail, collaboration, influence, negotiation, critical thinking, and problem-solving skills.
Required
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 5+ years
- 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
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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
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.
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.