Azurity Pharmaceuticals is a privately held specialty pharmaceutical company dedicated to developing innovative medications for underserved patient populations. With a focus on cardiovascular, neurology, endocrinology, gastro-intestinal, and orphan markets, Azurity has made a significant impact on millions of patients worldwide. The company prides itself on its patient-centric approach, high-quality medications, and robust late-stage pipeline.
Azurity is also committed to fostering an inclusive workplace and is an Equal Opportunity Employer. Their success is driven by a talented and dedicated team that prioritizes patient well-being and scientific excellence.
Department Overview: Drug Safety Team
The Drug Safety team within Medical Affairs plays a pivotal role in ensuring patient safety by monitoring, evaluating, and reporting adverse events across all stages of a product’s lifecycle. This team collaborates closely with Regulatory Affairs, Clinical Development, and Quality teams to maintain compliance with global pharmacovigilance regulations and uphold the highest standards of patient safety.
Clinical Safety Specialist: Key Responsibilities
As a Clinical Safety Specialist, you will be responsible for evaluating and managing clinical safety data to ensure patient safety during drug development and post-marketing processes. Your primary duties will include:
- Reviewing and assessing adverse event (AE) reports from clinical trials, post-market surveillance, and spontaneous/literature reports.
- Ensuring timely and accurate reporting of serious adverse events (SAEs) to regulatory authorities such as the FDA, EMA, and other relevant bodies.
- Preparing and reviewing clinical safety documents, including Safety Management Plans (SMPs), Clinical Safety Reports (CSRs), and clinical protocols.
- Ensuring compliance with GxP, ICH guidelines, and other pharmacovigilance regulations.
- Participating in audits and inspections by regulatory authorities or internal audit teams.
- Collaborating with clinical research teams to assess safety data, identify adverse events of special interest (AESIs), and ensure timely reporting.
- Supporting the preparation of safety-related sections in clinical trial protocols and business development reviews.
- Designing and executing safety surveillance strategies for clinical trials, including interim safety analyses and risk assessments.
Qualifications and Requirements
To be considered for the Clinical Safety Specialist role, you should meet the following criteria:
- Educational Background: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field. Advanced degrees (MS, PhD, PharmD) are a plus.
- Experience: 3+ years of experience in pharmacovigilance, drug safety, clinical research, or a related field.
- Technical Skills: Proficiency in pharmacovigilance software systems such as Argus and MedDRA.
- Regulatory Knowledge: Familiarity with FDA, EMA, and ICH guidelines.
- Analytical Skills: Strong ability to review, analyze, and interpret clinical safety data.
- Communication Skills: Excellent written and verbal communication skills for interacting with regulatory authorities, clinical teams, and external stakeholders.
- Collaboration: Ability to work effectively in cross-functional teams.
Physical and Mental Requirements
The role of a Clinical Safety Specialist involves:
- Sitting for long periods of time.
- Occasionally lifting and moving up to 25 pounds.
- Operating a keyboard, telephone, and hand-held devices.
- Climbing stairs or riding elevators as needed.
Reasonable accommodations will be made for individuals with disabilities.
Why Join Azurity Pharmaceuticals?
- Impactful Work: Contribute to the development of life-changing medications for underserved patient populations.
- Collaborative Environment: Work with a talented and dedicated team that values integrity and innovation.
- Career Growth: Opportunities for professional development in a growing pharmaceutical company.
- Inclusive Culture: Be part of an organization that values diversity and inclusion.
