Pharmacovigilance Compliance Manager

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:

Our global Pharmacovigilance team at Azurity is working to ensure reliable safety profile of the drugs to bring on the market efficient and save treatments for patients. We are looking for a dynamic, quality-inspired compliance manager to lead compliance PV activities and support team in inspection readiness.

Principle Responsibilities:

• Collect and communicate metrics data as related to the ongoing assessment of Pharmacovigilance (PV) quality, consistency, operational effectiveness and compliance.
• Coordinate developing, update and maintain PV-related procedures in collaboration with quality assurance and other subject matter experts.
• Contribute to PV training and ensuring training compliance for PV team in collaboration with Quality Assurance.
• Work closely with Quality Assurance on developing processes related to pharmacovigilance quality and compliance.
• Ensure PV system readiness to inspections and audits.
• Maintain the PV audits plan, coordinate PV audit preparation activities applicable to internal, vendor and business partner audits.
• Coordinate and contribute to PV Corrective Action/Preventive Action (CAPA) Plans in Veeva including training, response strategy, root-cause analysis and documentation.
• Monitor implementation of post-marketing pharmacovigilance commitments and responses to audit observations
• Identify and manage deviations, tracking and root analysis within Veeva, ensuring compliance improvement of the PV system.
• Process quality control of open cases/ICSRs and upcoming submissions ensuring compliance of relevant timelines and quality control of other PV Case Management activities
• Contribute to change control lifecycle activities impacting the PV System, as needed, in alignment with Global Quality internal policies and procedures
• Cooperate with Qualified Person for Pharmacovigilance, (QPPV) oversee Pharmacovigilance Safety Master File (PSMF) contributors provide timely, accurate updates and completion of PSMF
• Quality control of aggregate safety reports and signal detection reporting in line with international regulations, Health authorities' guidelines, and internal standards, appropriate control of timely safety reporting and risk management activities
• Escalate issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management

Qualifications and Education Requirements

• Degree in healthcare science such as B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent.

Experience Requirements

• A minimum of 3-5 years of pharmaceutical industry experience, including 3 years of pharmacovigilance, drug development, clinical development, or regulatory affairs experience specifically involving Safety Database case processing.
• Prior experience in IT project management, including Veeva, and SharePoint management
• Strong scientific background in a life science-related field.
• Prior quality-related experience in pharmacovigilance

Operational Skills

• Technical Proficiency: Experienced in advanced functionalities of operational tools and integrates digital automation tools into daily workflows.
• Process Management: Optimizes existing processes through incremental improvements and digital enhancements.

Analytical Skills

• Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data.
• Critical Thinking: Evaluates different options based on evidence and context to form reasoned judgments.
• Data Management: Monitors and reviews data for deviations and patterns that could impact workflow or output quality.

#LI-Hybrid

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

Benefits We Offer:

• Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.

• Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.

• Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.

• Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.

• Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions

• Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.

• Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.

• Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.

• Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.

• Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.

• Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.

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