Safety Reporting Coordinator, Bulgaria
5 months ago
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.
As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.
- Discover Impactful Work:
Provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects.
Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues.
May also be involved in updates to procedures and other initiatives related to safety reporting.
May mentor or train new central safety reporting staff.
- A day in the Life:
- Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation.
- Assists in producing metrics and alerts manager to any quality or timeline issues.
- Ensures timely maintenance of safety reporting systems and information.
- Liaises with various departments and extenal parties (including clients) in relation to safety reporting tasks and the setting up and maintenance of projects.
- Good understanding of SOPs, GDs and project related documentation.
- Proactively troubleshoots daily operational issues with limited input from management.
- With support of management, provides updates to the operational safety reporting team and Senior Management in relation to work deliverables / status as required and in accordance to regulatory requirements.
- Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
- Responsible for training Pharmacovigilance department staff on the safety reporting process and various systems associated with safety reporting.
- Assists with, and may participate in, audit and inspection preparation if required or requested by the company or client.
- Knowledge of, and ability to perform against, KPIs for projects.
- Keys to Success:
**Education**
- Bachelor's degree
**Experience**
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
**Knowledge, Skills, Abilities**
- Ability to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks.
- Ability to work effectively as an individual and independently to attain the wider goals of the team.
- Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint).
- Good knowledge of Pharmacovigilance and industry terminology.
- Strong written and verbal communication skills, including telephone conversations as well as face to face interaction internally within the department.
- Ability to identify and prioritize tasks simultaneously along with handling numerous deadlines and stay focused during these times
- Ability to work under pressure without jeopardizing work standards.
- Ability to interact effectively with all levels of the organization.
- Possess the maturity to handle sensitive information and data effectively.
- Strong knowledge of procedural documents with the ability to identify gaps in processes and offer constructive suggestions for solutions.
- Strong attention to detail.
- Strong organization and time management skills with proven ability to handle multiple tasks at once and deal effectively with pressure.
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to crea
-
Senior Safety Reporting Coordinator
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a skilled Safety Reporting Coordinator to join our team at Thermo Fisher Scientific. In this role, you will be responsible for providing administrative safety support to the safety reporting team and Pharmacovigilance department.Key ResponsibilitiesProvide administrative safety support to the safety reporting team and...
-
Senior Safety Reporting Coordinator
2 months ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Safety Reporting Coordinator to join our team at Thermo Fisher Scientific. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety and quality of our clinical trials.Key ResponsibilitiesProvide administrative support to the safety reporting...
-
Senior Safety Reporting Coordinator
2 months ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Safety Reporting Coordinator to join our team at Thermo Fisher Scientific. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety and quality of our clinical trials.Key ResponsibilitiesProvide administrative support to the safety reporting...
-
Senior Safety Reporting Coordinator
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, we're committed to making a positive impact on a global scale. As a Senior Safety Reporting Coordinator, you'll play a crucial role in enabling our customers to achieve their goals while improving health outcomes.Our Pharmacovigilance team is responsible for managing the safety profile of new drugs in clinical trials, overseeing...
-
Senior Safety Reporting Coordinator
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Senior Safety Reporting Coordinator, you'll play a critical role in achieving this mission by managing the safety profile of new drugs in clinical trials, overseeing case-processing activities, and performing regulatory reporting and...
-
Senior Safety Reporting Coordinator
1 month ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAbout the RoleAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Senior Safety Reporting Coordinator, you'll play a critical role in our Pharmacovigilance team, ensuring the safety profile of new drugs in clinical trials.Key ResponsibilitiesProvide administrative safety support to the...
-
Senior Safety Reporting Coordinator
1 month ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAbout the RoleAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Senior Safety Reporting Coordinator, you'll play a critical role in our Pharmacovigilance team, ensuring the safety profile of new drugs in clinical trials.Key ResponsibilitiesProvide administrative safety support to the...
-
Senior Safety Reporting Coordinator
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world a healthier, cleaner, and safer place. As a Senior Safety Reporting Coordinator, you'll play a critical role in this mission by managing the safety profile of new drugs in clinical trials, overseeing case-processing activities, and performing regulatory reporting and...
-
Senior Safety Reporting Coordinator
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, we're dedicated to making a positive impact on a global scale.We're seeking a highly skilled Safety Reporting Coordinator to join our team and contribute to the success of our Pharmacovigilance department.About the Role:Provide administrative safety support to the safety reporting team and Pharmacovigilance department.Responsible...
-
Senior Safety Reporting Coordinator
2 months ago
Cambridge, United Kingdom Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...
-
Fire Safety Coordinator
5 months ago
Cambridge, United Kingdom University of Cambridge Full time**The Role**: The Fire Safety Coordinator provides specialist technical, commercial and administrative support to the Fire Safety Team within Estates Operations, which comprises a Fire Safety Manager, a Deputy Fire Safety Manager, and a Fire Safety Advisor. The team has responsibility for ensuring high standards of fire safety across the University Estate,...
-
Safety Reporting Specialist, Uk
5 months ago
Cambridge, United Kingdom Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Safety Reporting Specialist, Uk
5 months ago
Cambridge, United Kingdom Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Safety and Environmental Coordinator
6 months ago
Cambridge, United Kingdom University of Cambridge Full timeThe Department of Zoology is very friendly and welcoming and is also internationally renowned for its exceptional record in teaching and research. We are now looking for a Safety and Environmental Coordinator - a proactive, enthusiastic and versatile individual with a collaborative and hands-on approach to undertake this important role. The role holder will...
-
Health & Safety Trainee
5 months ago
Cambridge, United Kingdom Encore Estate Management Full timeAre you looking to start a career in Health & Safety by gaining a qualification and real world work experience? If so, here at Encore we have the perfect role for you! We are looking for a detail orientated individual to come and join us as a Health & Safety Trainee. The successful will undertake their NEBOSH General Certificate & NEBOSH Fire Certificate...
-
Safety Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Marshall Full timeAbout the Role:We are seeking a skilled Safety Specialist to join our team at Marshall. As a Safety Specialist, you will contribute to all engineering safety activities and documentation, promote best practices in safety engineering, and provide guidance to our engineering team.Key Responsibilities:Support the development and maintenance of safety...
-
Safety Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Marshall Full timeAbout the Role:Marshall is seeking a skilled Safety Engineer to contribute to all engineering safety activities and documentation, promote best practices in safety engineering, and provide guidance to our engineering team.Key Responsibilities:Support the development and maintenance of safety engineering processes, tools, and templates to ensure compliance...
-
Health Safety Manager
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Skanska Full timeAbout the RoleSkanska is seeking a Health Safety Manager to join our Infrastructure team on the A428 project. The successful candidate will provide high-quality advice, guidance, and coaching to senior management to achieve the goal of zero accidents.Key ResponsibilitiesEnsure compliance with and reporting on performance of the Company HSMS and statutory...
-
Safety Leadership Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Opus People Solutions Full timeJob Title: Lead Busway Safety OfficerJob Summary: We are seeking a highly skilled and experienced Lead Busway Safety Officer to join our team at Opus People Solutions. The successful candidate will be responsible for leading all safety-related activities, including risk assessments, incident investigations, and stakeholder engagement.Key...
-
Health Safety Manager
1 month ago
Cambridge, Cambridgeshire, United Kingdom Skanska Full timeAbout the RoleSkanska, a leading project development and construction group, is seeking a Health Safety & Wellbeing Manager to join its Infrastructure team on the A428 project. The purpose of this role is to provide high-quality advice, guidance, and coaching to senior management to achieve the goal of zero accidents.Key ResponsibilitiesEnsure compliance...
