Senior Safety Reporting Coordinator

3 weeks 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.

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.

A day in the Life:

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 with allocation of work tasks to safety reporting team members as well as oversight for completion of work tasks by others.

Provides assistance with planning and coordination of large and complex projects relating to safety reporting. With input and supervision from superiors, leads complex projects including project oversight and collation, maintenance, and delivery of metrics.

Recommends and performs updates to procedures, regulatory intelligence activities and other initiatives related to safety reporting.

Provides training, guidance, and support to safety reporting team members.

Keys to Success:

Education:

Bachelor's degree in life science/healthcare-related courses (nursing, pharmacy, biology, med tech, etc)

Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).

Knowledge, skills and abilities:

Ability to work effectively in a team environment, and as a lead, to attain a shared goal and support line manager on tasks.

Ability to work effectively as an individual and independently to attain the wider goals of the team

Excellent proficiency in Microsoft Office Programs (Word, Excel, PowerPoint)

Strong knowledge of Pharmacovigilance and industry terminology

Excellent 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, for self and others, 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 and to act accordingly as required

Excellent knowledge of procedural documents with the ability to identify gaps in processes and offer constructive suggestions for solutions performing review and updates as required

Excellent critical thinking and problem solving skills and attention to detail

Excellent organization and time management skills with proven ability to handle multiple tasks at once and deal effectively with pressure while maintaining 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

Demonstrates initiative and utilizes persuasion and negotiation skills to influence colleagues and team peers

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