Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit
www.azurity.com.Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
The Medical Affairs Group at Azurity is hiring a highly motivated Drug Safety Associate to join the team. This individual will report to the Director of Drug Safety and will support Pharmacovigilance activities across the organization. This individual will leverage existing industry knowledge, organizational and communication skills to support ongoing drug safety initiatives while maintaining compliance.
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
- Assist in managing and tracking reconciliations between partners
- 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
- Maintains the integrity of confidential information throughout the work process
Qualifications and Education Requirements
- Bachelor’s or master’s degree in life science or healthcare-related field
- OR equivalent combination of education and experience (i.e., an information science degree with at least 3 years of relevant working knowledge of supporting drug and patient safety)
- 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
- Possess experience with literature databases
- Possess excellent communication and organizational skills and the ability to work in a fast-paced environment
- Possess experience with 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
- High degree of responsibility and accountability and responsiveness
- Ability to develop cooperative working relationships with all levels of staff
- Conversant in medical terminology
- MedDRA coding
- Maintains comprehensive proficiencies with Adobe Acrobat and Microsoft Office (e.g., Word, Excel, and PowerPoint) and associated modules
- Capable of working in a team-oriented and rapidly changing environment
- Possess a working knowledge and an understanding of FDA Regulations
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
- Other miscellaneous job duties as required
