Safety Reporting Coordinator - Cambridge, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Cambridge, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Our team of colleagues in clinical research services are at the forefront of getting cures to market.

We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns.

Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global contract research organization (CRO).

Safety Reporting Coordinator - Cambridge, UK - Flex Office-Based (2-3 days Home-Based)
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.

Location/Division Specific Information

Our detailed, goal-oriented team members 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 tasks.

Discover Impactful Work:

Safety Reporting Administrator's provide administrative support to the Pharmacovigilance department, specifically in relation to submissions, tracking and subsequent filing and archiving of expedited and periodic safety reports.

At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We offer continued career advancement opportunities, award-winning training and benefits focused on the health and wellbeing of our employees.

A Day in the Life:
Provides administrative safety support to the Pharmacovigilance department. Specifically, in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks, such as filing, photocopying, typing and performing reconciliation tasks. Involved in projects relating to safety reporting. May mentor or train new central safety reporting admin staff.

Essential Functions:

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. Resolves simple problems with submission packs within mínimal input from manager or other administrators.
Responsible for extracting and collating reporting information via the Clinical Trial Management System, maintain and update contact lists on PPD systems as required by Safety Specialist or Safety Reporting Specialists.
Supports department and Pharmacovigilance initiatives as relevant. Responsible for training Pharmacovigilance department staff on the safety reporting process and various PPD systems associated with safety reporting.
Assists 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.
Assists with file reviews for completed safety reports, maintains audit notification and file return notification forms and provides assistance with onsite audits if required or requested by PPD or client.
Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.

Keys to Success:

Education and Experience:

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 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.

Skills and Abilities:

Ability to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks
Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint, Access) and proven knowledge of procedural documents
Excellent written and verbal communication skills, including telephone conversations as well as face to face interactions with all levels of the organization
Excellent organisation a