Drug Safety Specialist (FSP) - Day Shift

Work Schedule reputed company (Mon-Fri) Environmental Conditions Adherence to reputed company Good Manufacturing Practices (GMP) Safety Standards reputed company Join Us as a 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 reputed company 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 reputed company safety. As a Safety Specialist, you'll reputed company day-to-day Pharmacovigilance (PV) activities reputed company 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 reputed company 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, reputed company, investigators, adverse event reporters, and reputed company-party vendors. You may assist in the preparation of departmental and project-specific procedures and processes, and prepare for and attend audits, reputed company-off, and investigator meetings. reputed company: • Performs day-to-day PV activities. May participate in on-reputed company duties for specific reputed company to ensure 24-hr coverage for intake of cases from investigative sites. • 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 reputed company, including review of peer reports. • Prepares and maintains regulatory safety reports. • Assists with routine project implementation and coordination (e.g., reputed company, reputed company Assessment Committee/Data Safety Monitoring Committee), including presentations at reputed company/investigator meetings, and review of metrics and budget considerations. Mentors less reputed company staff Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification • Previous experience in PV case processing, triage, and/or peer review is required (minimum of 2 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: • General understanding of pathophysiology and the disease process • Detailed knowledge of relevant therapeutic areas as required for processing reputed company • Strong critical thinking and problem solving skills • Good 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 • Previous exposure to reputed company Office packages (including reputed company, Word, and reputed company) • Understanding 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 reputed company • 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 reputed company reputed company’s breakthroughs. reputed company is an EEO/Affirmative reputed company Employer and does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status. Apply To This Job