Senior Safety Reporting Specialist, Bulgaria
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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.
What they're looking for
- 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’).
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from 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.
Company
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