Safety Reporting Coordinator, Bulgaria

6 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.

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.
- Discover Impactful Work:
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 management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects.

Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues.

May also be involved in updates to procedures and other initiatives related to safety reporting.

May mentor or train new central safety reporting staff.
- 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.
- Ensures timely maintenance of safety reporting systems and information.
- Liaises with various departments and extenal parties (including clients) in relation to safety reporting tasks and the setting up and maintenance of projects.
- Good understanding of SOPs, GDs and project related documentation.
- Proactively troubleshoots daily operational issues with limited input from management.
- With support of management, provides updates to the operational safety reporting team and Senior Management in relation to work deliverables / status as required and in accordance to regulatory requirements.
- Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
- Responsible for training Pharmacovigilance department staff on the safety reporting process and various systems associated with safety reporting.
- Assists with, and may participate in, audit and inspection preparation if required or requested by the company or client.
- Knowledge of, and ability to perform against, KPIs for projects.
- Keys to Success:
**Education**
- Bachelor's degree

**Experience**
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

**Knowledge, Skills, Abilities**
- Ability to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks.
- Ability to work effectively as an individual and independently to attain the wider goals of the team.
- Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint).
- Good knowledge of Pharmacovigilance and industry terminology.
- Strong 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 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.
- Strong knowledge of procedural documents with the ability to identify gaps in processes and offer constructive suggestions for solutions.
- Strong attention to detail.
- Strong organization and time management skills with proven ability to handle multiple tasks at once and deal effectively with pressure.

**Work Environment**

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to crea

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