Drug Safety Associate
About the position Responsibilities • Assist in maintaining compliance with Pharmacovigilance (PV) activities in accordance with company policies, SOPs, and FDA regulations. • Assist in safety agreement editing, renewal tracking, and formatting. • Assist with the management and oversight of safety-related information. • Assist with individual case review and management including company-sponsored clinical trials. • Assist with the management of the core drug safety email system. • Manage daily workflows and communications cross-functionally to ensure timely responses to partners. • Assist in the review, oversight, and organization of weekly and monthly safety reports. • Assist in organizing safety project management internal tools. • Assist in reviewing, organizing, and authoring standard operating procedures. • Assist in maintaining electronic files to ensure the filing of applicable documents to ensure audit readiness. • Assist in reviewing Expedited and Non-expedited safety reports and source documents including review for completeness and accuracy. • Contribute adverse event information for safety reports including Periodic Adverse Drug Experience Reports (PADERs), Post-Marketing Periodic Safety Update Reports (PSURs) as well as safety data for clinical reports. • Assist in maintaining pertinent workflows to increase the quality and submission of reports. • Assist in the preparation and editing safety related training materials. • Collaborate with other departments to ensure the timely processing of reports. • Maintain the integrity of confidential information throughout the work process. Requirements • Bachelor's or master's degree in life science or healthcare-related field OR equivalent combination of education and experience. • At least 3 years of experience reviewing individual case reports, aggregate reports and literature for adverse event reporting. • Strong analytic ability to analyze and summarize the main points of case reports, studies, and/or specific topics. • Experience with literature and safety databases. • Problem-solving skills, especially with respect to enforcing safety rules and global procedures as described in SOPs, Operational Manuals, and Guidance Documents. • Excellent written/oral communication skills are essential including fluency in English. • Proactive behavior and ability to keep timelines in a fast-paced environment. • Ability to develop cooperative working relationships with all levels of staff. • Conversant in medical terminology; familiarity with MedDRA coding. • Comprehensive proficiencies with Adobe Acrobat and Microsoft Office (e.g., Word, Excel, and PowerPoint) and associated modules. • Working knowledge and understanding of FDA Regulations. • Ability to work independently and as part of a team in a fast-paced environment. Benefits • Competitive compensation package, including an annual bonus based on company performance. • Incentive compensation program for sales roles. • Car reimbursement program and gas card for business and personal use for sales roles. • Excellent medical, dental, vision, and prescription coverage. • Hybrid work model allowing two days from home and three days in the office. • 401K retirement savings plan with dollar-for-dollar matching up to 5%. • Generous time off policy, offering up to 15 vacation days annually + rollover (up to 40 hours) and five sick/wellness days. • Extra week off between Christmas and New Year's. • Recognition of 13 holidays throughout the year. • Tuition reimbursement for undergraduate and graduate level courses or certifications. • Azurity High Five peer recognition platform. Apply tot his job