Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

• 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.
• 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.

• Bachelor's degree or equivalent experience in a relevant field.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Strong critical thinking and problem-solving skills.
• Good oral and written communication skills, including paraphrasing skills.
• General understanding of pathophysiology and the disease process.
• Detailed knowledge of relevant therapeutic areas as required for processing adverse events (AEs).
• Good command of English and the ability to translate information into the 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 and a proven ability to maintain a positive and professional demeanor in challenging circumstances.
• Ability to work effectively within a team to attain a shared goal.