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.
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