Senior Safety Reporting Coordinator

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior Safety Reporting Coordinator Make an Impact at the Forefront of Innovation

At Thermo Fisher Scientific youll 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.

The Senior Safety Reporting Coordinator provides administrative safety support to the Pharmacovigilance department specifically in relation to submissions tracking and subsequent filing and archiving of expedited and periodic safety this role you will lead projects and provide guidance and support to team members in the resolution of problems. You may also be involved in updates to procedures and other initiatives related to safety reporting and may mentor or train new central safety reporting administration staff.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

What Youll Do:
Responsible for the submission of safety reports to applicable parties including subsequent scanning indexing and filing (both electronic and paper) safety tracker completion and quality check and archiving in accordance with SOPs and WPDs. Resolve complex issues with submission packs through discussion with Safety Specialists or Safety Reporting Specialists with minimal input from your Manager.
Assist in the receipt and preparation of safety report submissions including log sheet or electronic system entry cover letter and third-party email preparation.
Provide assistance and direction to team members and liaise with relevant departments on a range of administrative safety reporting tasks including audit readiness activities developing training materials meeting organization minute taking filing photocopying work distribution reconciling reports end-of-day emails collation of metrics and updating the organizations systems with project allocation.
Responsible for extracting and collating reporting information via the Clinical Trial Management System maintaining and updating contact lists on the organizations systems as required by Safety Specialists or Safety Reporting Specialists. Troubleshoot and provide support to the team on arising issues.
Support and lead department and Pharmacovigilance initiatives as relevant.
Provide training to Pharmacovigilance department staff on the safety reporting process and procedures and relevant associated systems including the creation of training materials.
Assist when required to provide filing support for multiple projects including barcoding of safety reports filing of safety reports identification and reporting of any problems and inaccuracies to management as well as responsibility for the file room in terms of cleanliness and organization.
Assist with file reviews for completed safety reports maintain audit notification and file return notification forms and provide assistance with on-site audits if required or requested by the organization or client.
Responsible for the coordination of study files and inventories to clients including distribution via external postal services as needed.

Education and Experience Requirements:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to at least 4 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:
Ability to work effectively in a team as well as independently to attain the wider goals of the team
Excellent critical thinking and problem-solving skills
Proactive and uses initiative to solve complex problems
Proficiency in Microsoft Office Programs (Word Excel PowerPoint Access) and excellent knowledge of procedural documents
Excellent written and verbal communication skills including telephone conversations as well as face-to-face interaction
Excellent organization and time management skills including those of paperwork and files with proven ability to handle multiple tasks at once and deal effectively with stress
Excellent attention to detail and accuracy with orientation towards careful and meticulous work
Ability to apply knowledge skills and expertise to assist other colleagues in safety reporting activities

Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Work is performed in an office environment with exposure to electrical office equipment
Potential drives to site locations and/or travel required on rare occasion
Majority of work computer-based
Long varied hours required on occasion

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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.