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Job Description
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.
Summarized Purpose:
Responsible for the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues. Leads projects and programs and provides guidance and support to other team members. May also be involved in updates to procedures, regulatory intelligence activities and other initiatives related to safety reporting.
Essential Functions
- Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis.
- Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines.
- Provides input and feedback to aid the development of program and departmental procedural documents.
- Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions.
- Liaises with relevant departments around safety reporting tasks and attends various meetings as required.
- Provides input, feedback and guidance to other team members and mentors new starters.
- Produces metrics and has some involvement in financial project.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, and experience.
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 details.
- 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:
We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
What we offer:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD® clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
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.
Apply today! http://jobs.thermofisher.com
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
