Drug Safety Scientist

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.

Brief role description

Providing scientific and pharmacovigilance expertise to core drug safety deliverables and activities for Azurity pharmaceuticals developmental and marketed products including but not limited to the preparation and review of scheduled or ad hoc aggregate safety reports, PADER, RMP and REMS. Perform activities related to safety signal detection and support benefit/risk management efforts. This individual will report to the Senior Director of Drug Safety/Director Pharmacovigilance and will support Pharmacovigilance activities across the organization. Work collaboratively with external partners and other functions across Azurity Pharmaceuticals, including Clinical Development, Quality Assurance, Regulatory Affairs, and Medical Affairs.

Principle Responsibilities

• Perform medical monitoring and pharmacovigilance activities (such as medical oversight of the study, eligibility checks, review safety data)


• Perform safety review of clinical and post-marketing data as part of case processing and aggregate reporting.


• Provide medical review, causality assessments of ICSRs, contributing to aggregate reports (DSUR, PSUR/PBRER, PADER) as applicable


• Perform Signal detection and literature review including relevant outsourced activities


• Contribute to development of clinical documents from drug safety e.g., to review clinical study protocols or other clinical documents like safety management plan, medical monitoring plan.


• Contribute to maintaining compliance with Pharmacovigilance (PV) activities to ensure inspection readiness in accordance with company policies, SOPs, EMA  and FDA regulations


• Contribute to the management and oversight of safety-related information reported with possible product complaints, from clinical trials and any other sources.


• Perform case processing activities including triage, data entry, adverse event extraction and ranking, selecting, or verifying the appropriate coding (using MedDRA and the WHO Drug Dictionary), narrative preparation/review, and case submissions including the reports received from clinical trials.


•  Perform ICSR downloads from Eudravigilance, MHRA Portal, Canada Vigilance and other Health authorities’ portals on a weekly manner and perform case processing of these report


• Contribute to the management of the core drug safety email system managing and tracking reconciliations between partners


• Maintaining electronic files and PV activities trackers to ensure the filing of applicable documents to ensure reporting compliance and timelines


• Assist in reviewing Expedited and Non-expedited safety reports and source documents including


• review for completeness and accuracy


• Assist in the preparation and editing safety related training materials


• Collaborate with other departments to ensure the timely processing of reports

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, cumulative listings and scientific literature database search for adverse event reporting and signal detection


• Strong analytic ability to analyze and summarize the main points of case reports, studies, and/or specific topics


• Advanced experience in Safety Signal Detection and Risk Management process


• Possess experience in development of aggregate reports/PSURs, PADERs, Risk Management Plan and REMS


• Possess excellent communication and organizational skills and the ability to work in a fast-paced environment


• Possess experience with safety databases including case processing/triaging, medical review and Quality Control of ICSRs


• 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 knowledge


• Capable of working in a team-oriented and rapidly changing environment


• Robust knowledge of EMA and FDA Regulation

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