Sr Safety Spec

Position Overview

• Location Type: [Not Specified]
• Job Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Environment: Office
• Salary: [Not Specified]

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 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:

As a Senior Safety Specialist, you will perform and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to 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, and adverse event/ reporters, and third-party vendors.

A Day in the Life:

• 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, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.

Keys to Success:

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Knowledge, Skills, 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 the 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 environment.