Safety Reporting Specialist, Uk

4 months ago

Cambridge, United Kingdom Thermo Fisher Scientific Full time

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.

**Discover Impactful Work**:
Our detailed, goal-oriented team members handle the safety profile of new drugs in clinical trials, lead all aspects of case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

**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.
- Participates on project teams and may lead projects of small to moderate scope.
- Provides training and support to other team members.
- Performs administrative tasks such as filing and the maintenance of safety
- reporting systems and information.
- Liaises with various departments around safety reporting tasks and the setting
- up of client accounts.
- Participates in audits where required and performs testing activities as needed.
- Shares ideas and suggestions with team members ensuring effective
- communication and participates in process improvement initiatives.

**Keys to Success**:
**Education**:
Bachelor's degree

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

**Experience**

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ 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, 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 successfully with all levels of the organization
- Strong critical thinking and problem-solving skills

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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