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 team/department description:
The Medical Affairs Group at Azurity is hiring a highly motivated Drug Safety Associate to join the team. This individual will report to the Vice President, Global 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.
Principle Responsibilities:
- Support implementation, execution, and maintenance of global risk management programs, including REMS (US), RMPs/PPP (EU), and other region-specific risk minimization activities.
- Assist in development and maintenance of procedures, training materials, and operational workflows supporting pharmacovigilance and risk management programs. · Monitor program effectiveness by tracking key metrics, patient education activities, and healthcare provider compliance controls.
- Support management of program deviations, CAPAs, and inspection readiness activities to ensure regulatory compliance.
- Coordinate with internal teams and external vendors to support administration of risk management programs and patient support services.
- Assist in preparation for health authority inspections, audits, and responses related to risk management activities.
- Support development, review, and maintenance of Risk Management Plans (RMPs) in alignment with global regulatory requirements and evolving safety data.
- Coordinate cross-functional input from safety, regulatory, and medical teams to support risk assessment and risk minimization activities.
- Track regulatory commitments, milestones, and deliverables associated with RMPs and risk management programs.
- Collaborate with signal detection and aggregate reporting teams to support incorporation of emerging safety data into RMP updates.
- Assist in preparation of regulatory submissions and responses related to pharmacovigilance and risk management commitments.
- Support pharmacovigilance planning and execution for product launches, including tracking timelines, deliverables, and cross-functional dependencies.
- Assist in ensuring PV system readiness across all lifecycle phases (Build, Submission, and Post-Launch).
- Identify and escalate potential risks that may impact compliance or regulatory timelines.
- Coordinate responses to safety-related inquiries from internal stakeholders and regulatory authorities.
- Maintain project plans and trackers to support PV programs, ensuring accurate tracking of milestones, deliverables, and dependencies.
- Provide routine updates on timelines, risks, and progress to internal stakeholders.
- Collaborate cross-functionally to ensure alignment on priorities, timelines, and deliverables across PV programs.
- Participate in cross-functional meetings and governance forums supporting pharmacovigilance initiatives.
- Support continuous improvement initiatives by identifying process gaps and contributing to development of standardized tools and workflows.
- Assist in documenting and implementing process improvements to enhance compliance, efficiency, and consistency across PV operations.
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
- Possesses 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
- Maintains comprehensive proficiency with Adobe Acrobat and Microsoft Office (e.g., Word, Excel, and PowerPoint) and associated modules
- Possess a working knowledge and an understanding of global health authority regulations
- Ability to work independently and as part of a team in a fast-paced environment.
#LI-Hybrid
