Manager, Pharmacovigilance

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 Manager, Pharmacovigilance to join the Pharmacovigilance team. This individual will report to the Senior Director of Drug Safety/Director Pharmacovigilance 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 timely while maintaining compliance and contribute to the overall development of pharmacovigilance strategies

 Principle Responsibilities

• Providing leadership in the assigned pharmacovigilance projects, supervision of outsourced drug safety operational and reporting activities with adherence to compliance and timelines


• Contribute to signal detection and safety risk management practices including Risk Management Plan


• Review of safety information from various sources including ICSRs, weekly literature monitoring, signal detection and safety aggregate reports


• Supervision of vendor case review and contributing to expedited reporting


• Quality review of case reports, product quality complaints with and without adverse reactions


• Prepare scheduled/ad-hoc periodic reports (including PSURs, DSURs)


• Provide content for the safety sections of regulatory documents. Author relevant sections of responses to safety related health authority requests


• Collaborate with other SMEs to develop, improve, and align pharmacovigilance procedures and documentation including SOPs, conventions, forms, templates or other internal documents when required


• Ensure that current safety reference documents are available and consistently utilized for ICSR assessing, aggregate reports generation and safety data analyses


• Support internal and external audits and Pharmacovigilance inspections readiness, contribute to the implementation of relevant corrective/preventive actions


• As needed, interact with external customers and service providers including business partners, CROs, system vendors and the call center


• Maintain an up-to-date working knowledge of Azurity products as well as applicable regulatory requirements, guidelines, and industry standards globally to ensure reliable benefit-risk balance of relevant products


• Contributing to PSMF review and supervision of QPPV activities including Local QPPV


• Contributing to Pharmacovigilance compliance as applicable


• Participating in cross-functional pharmacovigilance training

Qualifications and Education Requirements

• Academic degree in Pharmacy/Medicine/Biology


• At least 3-5 years of experience in the Biotech Pharmaceutical Industry or within CRO


• Thorough knowledge of Pharmacovigilance regulations, case processing and triaging


• Experience with triaging and ICSR processing


• Experience in Safety Signal Detection, Literature search and Risk Management process


• Fluent written and spoken English language

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