Safety Specialist, Bulgaria

Work Schedule

Environmental Conditions

Job Description

Join Us as a Safety Specialist Make an Impact at the Forefront of Innovation
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.

As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Safety Specialist youll perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include the collection monitoring assessment evaluation research and tracking of safety information. You will coordinate and perform PV activities such as data entry coding assessment of adverse events case review follow-up tracking of reports and regulatory reporting activities. You will effectively collaborate with various parties such as project team members client contacts investigators adverse event reporters and third-party vendors. You may assist in the preparation of departmental and project-specific procedures and processes and prepare for and attend audits kick-off and investigator meetings.

What Youll Do:
Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. Providing holiday coverage.

Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations practices procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
Reviews cases entered for quality consistency and accuracy including review of peer reports.
Prepares and maintains regulatory safety reports.
Assists with routine project implementation and coordination (e.g. Clinical Trials Endpoint Assessment Committee/Data Safety Monitoring Committee) including presentations at client/investigator meetings and review of metrics and budget considerations. Mentors less experienced staff

Education and Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable 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.

Knowledge Skills and Abilities:
General understanding of pathophysiology and the disease process
Detailed knowledge of relevant therapeutic areas as required for processing AEs
Strong critical thinking and problem solving skills
Good oral and written communication skills including paraphrasing skills
Good command of English and ability to translate information into local language where required
Computer literate with the ability to work within multiple databases
Previous exposure to Microsoft Office packages (including Outlook Word and Excel)
Understanding the importance of and compliance with procedural documents and regulations
Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
Strong attention to detail
Ability to maintain a positive and professional demeanor in challenging circumstances
Ability to work effectively within a team to attain a shared goal

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.