Safety Reporting Specialist (Clinical Research)
Safety Reporting Specialist (Clinical Research)
Thermo Fisher Scientific
Job description
Thermo Fisher Scientific are looking for Safety Reporting specialist role at Hyderabad. This would be a great opportunity for healthcare professionals.
Company Description
Thermo Fisher Scientific is the world leader in serving science. With more than $44 billion in annual revenues, over 125,000 employees globally, and driven by the mission to enable customers to make the world healthier, cleaner and safer we provide unrivalled solutions in life science technologies, analytical instruments, specialty diagnostics and laboratory products.
Job Summary
The Associate Safety Reporting Specialist will support with the receipt, submission and monitoring of expedited and periodic safety reports throughout the projects within the department. You will support the management team with the creation of metrics for projects. You will also get involved in projects and programmes around safety reporting.
Key Responsibilities
The key responsibilities of a safety reporting specialist are:
Receiving, preparing and submitting safety reports. Ensuring they are submitted on time and in accordance with any country legislation.
Monitoring the submission of all expedited/periodic safety reports and having proof that they have been submitted.
Developing your project management skills by supporting your assigned lead. You may also lead on smaller projects.
Communicating with the appropriate teams around safety reporting and supporting your assigned lead.
Running reports. You will ensure the contact details within the repository/system are kept up to date.
Ensuring the regulatory submission folders and processes are created, set up, maintained and archived in accordance with our WPDs or clients SOPs.
Supporting the manager with the collation of metrics.
Educational Qualification
Educational qualifications required for Regulatory affairs specialists are:
Bachelor's degree in healthcare or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Skills Required
Skills required for safety reporting specialist are:
An understanding of medical terminology.
Excellent written and verbal communication skills.
Knowledge of Microsoft Office packages and an understanding of how the safety database works.
A basic understanding of procedures documentation and an understanding of worldwide safety reporting requirements. Including FDA regulations and guidelines.
Excellent organisation and time management skills.
Highly detailed and accurate.
Maturity to manage sensitive information.
The ability to communicate with all levels of the business.
The ability to work well in a team.
Salary Structure
The average salary for a Safety Reporting Specialist (Clinical research) at Thermo Fisher Scientific in Hyderabad is between ₹6.1L and ₹7.1L per annum.
Career Development
As a Safety Reporting Specialist you will be starting a long term career in Pharmacovigilance and Clinical Research. Thermo Fisher offer a clear progression path to become a Senior Specialist, Team Lead or Manager. There is also the opportunity to progress into other roles within the business such as Regulatory Affairs, Quality Assurance or Clinical Project Management. As part of your role you will gain hands on experience with safety databases (Argus) and knowledge of global regulations (FDA/EMA). You will continue to develop your knowledge and work with international teams to ensure patient safety and progression of life saving therapies.
How to Apply
Go to our jobs page and search for Safety reporting specialist (clinical research) at Thermo Fisher Scientific.
Click on the role to see further details.
Complete your details and upload your CV.
Submit your application.
Education
Bachelor's Degree
Key Skills
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Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.