ARAVAS INC

The Associate Director, Pharmacovigilance Operations oversees PV vendors and ensures all pharmacovigilance deliverables are on track. They also prepare safety governance meeting minutes and support quality management systems. | Candidates should have at least 5 years of experience in pharma/biotech, with a foundational understanding of pharmacovigilance regulations. Strong communication and organizational skills are essential for this role. | Role Description Reporting to the VP, Global Pharmacovigilance and Drug Safety, the Associate Director, Pharmacovigilance (PV) Operations focuses on PV operational support across vendor management (PV & EAP), safety governance, PV Quality Management Systems (QMS), and periodic safety reporting.  Core Responsibilities * PV Vendor Project Management: Oversee PV vendors including day-to-day service delivery and SLA performance monitoring, manage joint Safety Management Plans & review PV agreements and associated vendor/ partner process documents; coordinating IB/RSI communication to case management vendor for ICSR reporting, and ensuring all PV deliverables (aggregate safety/ periodic signal reports) are on track. * Safety Governance Support: Prepare and maintain minutes and action logs for safety governance meetings (e.g. Development Safety Team, QPPV monthly meetings). * PV QMS Support: Collate PV KPIs and compliance reports for Quality Management Review meetings and PSMF compliance reporting; assist with periodic/ ad-hoc PV-SOP updates, and support CAPA activities (tracking CAPA due dates, maintaining QMS documentation). * Periodic Safety report coordination: Work with cross-functional R&D internal stakeholders to gather relevant data for PBRERs, DSURs, and other safety reporting requirements, ensuring deadlines are met and quality standards maintained. * Maintain department SOPs and mandatory AE reporting training. * Operate in a confident and compliant manner within a highly regulated environment. * Stay up to date with therapy advances, regional PV regulatory requirements, medical scientific knowledge, and detailed knowledge of Savara’s products’ relevant disease areas. * Other duties and projects as assigned. Qualifications * At least 5 years of experience in pharma/biotech with at least 3 years of basic PV experience and a foundational understanding of PV regulations and concepts to enable effective vendor oversight. * Excellent written and oral communication skills are imperative. Ability to anticipate and adapt to change; strong interpersonal skills commensurate with the need to work closely with external vendors and internal team members. * Strong organizational skills and attention to detail. * Ability to work independently, complete tasks in a timely fashion, and function in a rapid-paced environment. Work Location and Travel This role is remote within the US and requires the ability to attend meetings in both US eastern time and European time zones. Travel to Savara's US HQ outside of Philadelphia is required (estimated quarterly); other domestic or international travel may also be required as-needed. Compensation and Benefits Savara's approach is to provide comprehensive compensation and benefits that are competitive within the job market, offer opportunities to recognize excellence in performance, and are equitable and accessible for all staff. The base range for this role is $140,000 to $160,000 annually, and the compensation package will include a bonus and equity. Savara provides comprehensive benefits including: * Medical, dental and vision coverage * FSA for health care and dependent care * Paid time off and paid holidays, including a week-long winter shut down * Paid parental leave * 401(k) with highly competitive match * Life, AD&D, STD and LTD insurance coverage About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.