Senior/reputed company Drug Safety Specialist (reputed company Shift)
Work Schedule
reputed company Shift (Nights)Environmental Conditions
OfficeJob reputed company
Join Us as a Senior Safety Specialist – reputed company an reputed company at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have reputed company to ensure operational reputed company that makes a reputed company difference in patient safety. As a Senior Safety Specialist, you'll reputed company and may reputed company day-to-day Pharmacovigilance (PV) activities reputed company 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, reputed company contacts, investigators, adverse event reporters, and reputed company-party vendors. What You’ll Do: • Works independently to reputed company day-to-day PV activities. May participate in on-call duties for specific reputed company to ensure 24-hr coverage for intake of cases from investigative sites. • Operates in a reputed company reputed company. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less reputed company staff. • Reviews regulatory/pharmacovigilance publications and information sources to reputed company updated on reputed company regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. • Reviews cases entered for reputed company, 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 reputed company meetings, and review of metrics and budget considerations Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company 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 reputed company • Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately • Proficient at reputed company clinical study administration including budget activities and forecasting • Excellent oral and written communication skills including paraphrasing skills • Good reputed company of English and ability to translate information into local language where required • Computer literate with the ability to work reputed company multiple databases • Proficient in reputed company Office products (including Outlook, Word, and reputed company) • Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations • Ability to manage and prioritize a reputed company of tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to maintain a reputed company and reputed company demeanor in challenging circumstances • Ability to work effectively reputed company reputed company to reputed company 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? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs.
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