Drug Safety (PV) Physician – Medical Governance & Oversight

<div class="content-intro"><p><span style="font-family: Arial; font-size: 12pt;">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 <a href="http://www.azurity.com/">www.azurity.com</a>.</span></p> <p><span style="font-family: Arial; font-size: 12pt;">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.</span></p></div><p><span style="text-decoration: underline; font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Brief team/department description: </strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The Medical Affairs Group at Azurity is hiring a highly motivated Drug Safety Physician to join the team. This role serves as the internal medical authority for Pharmacovigilance (PV) oversight at the sponsor level. While operational PV activities and medical case review are performed by an external safety vendor, this position ensures the company retains medical accountability and governance over all safety decisions. This is not a case processing role but a medical governance and oversight role critical for regulatory inspection readiness. </span></p> <p><span style="text-decoration: underline; font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Principle Responsibilities:&nbsp; </strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide medical governance oversight of vendor-performed medical case assessments and safety decisions</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Review and provide medical input for complex, serious, and medically significant ICSRs </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide medical review and oversight of signal detection and evaluation activities </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide medical input and oversight for aggregate reports (PBRER, PSUR, DSUR) </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Oversee medical review of literature surveillance conducted by vendor </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure appropriate benefit-risk evaluation across products</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate in vendor governance meetings and review medical KPIs and trends </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Serve as medical safety representative during audits and regulatory inspections </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide medical training and guidance to internal PV staff as needed </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure sponsor retains medical accountability for PV decisions</span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="text-decoration: underline;"><strong>Qualifications and Education Requirements </strong></span></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">MD or equivalent medical degree required</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">7+ years of experience in Pharmacovigilance or Drug Safety </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience with signal management and aggregate reporting </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience working in outsourced PV models strongly preferred </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong understanding of global PV regulations (FDA, EMA, MHRA) </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Inspection and audit experience required </span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to provide high-level medical judgment and governance oversight</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-size: 8pt; font-family: arial, helvetica, sans-serif;">#LI-Hybrid</span></p><div class="content-conclusion"><p><span data-olk-copy-source="MessageBody">By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.</span></p></div>