SeniorPrincipal Drug Safety Specialist (Night Shift)

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior 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 Senior Safety Specialist youll perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include but are not limited to the collection monitoring assessment evaluation research and tracking of safety information. You will effectively collaborate with various parties such as project team members client contacts investigators adverse event reporters and third-party vendors.

What Youll Do:
Works independently to perform 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.
Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff.
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.
Responsible for routine project implementation and coordination (e.g. Clinical Trials and Post Approval including presentations at client meetings and review of metrics and budget considerations

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 to 5 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:
Thorough understanding of pathophysiology and the disease process
Strong knowledge of relevant therapeutic areas as required for processing AEs
Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately
Proficient at complex clinical study administration including budget activities and forecasting
Excellent 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
Proficient in Microsoft Office products (including Outlook Word and Excel)
Thorough understanding of the global regulatory requirements and 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


Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment
Daily exposure to high pressure and intense concentration
Daily interactions with clients/associates
Long varied hours on occasion
Travel required on occasion domestic and/or international

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.