Associate Director, Pharmacovigilance

Description

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

We are seeking a highly motivated, experienced, and passionate individual to join our team as Associate Director, Pharmacovigilance at Ardelyx Inc. As a subject matter expert, you will play a pivotal role in ensuring the adherence of our pharmacovigilance (PV) activities to regulatory requirements, industry standards, company policies, and global regulations.

• Ensure compliance with regulatory standards by providing timely and accurate safety data outputs to relevant stakeholders like regulatory agencies and internal teams
• Collect, analyze, and provide accurate adverse event data from clinical trials and post-market surveillance assuring the generation of accurate reports
• Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level
• Serve as the primary liaison and point of contact for vendor operations including the PV vendor and/or vendors performing case management, case intake, literature review; call centers, including contract compliance, quality and timeliness of deliverables
• Perform critical oversight of safety vendors to ensure efficient, consistent, and compliant pharmacovigilance activities, requiring minimal supervision.
• Collaborate externally with Drug Safety vendors and business partners on case management issues, processes, and timelines to meet global regulatory requirements for adverse event reporting and data exchange obligations
• Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, including SUSAR and SAE communication to Ethic Committees and investigators as applicable
• Review and monitor CRO compliance through various reports and oversight activities, including tracking KPIs, metrics, and QC of SAE/ICSR cases in the safety database
• Oversee and direct reconciliation processes for case exchange with alliance partners as needed
• Manage PV-related deviations, quality issues, CAPA, effectiveness checks, and root cause analysis
• Oversee the end-to-end process of internal audits and regulatory inspections for all pharmacovigilance processes and systems
• Collaborate with cross-functional teams, such as Regulatory Affairs, Quality Assurance, Medical Affairs, and IT, to address quality and compliance-related issues and drive continuous improvement initiatives
• Provide guidance and support in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment and best practices
• Stay updated on changes in pharmacovigilance regulations, guidelines, and industry trends to ensure ongoing compliance and proactively address emerging requirements
• Contribute to process improvement initiatives and ensure consistency in aggregate reporting, clinical trial safety oversight, signal management, and response to ad hoc safety questions

• Bachelor’s degree in Life Sciences, Master’s degree is a plus, with 8 – 10 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry
• Experience working with a Pharmacovigilance database, with preference given to experience with Argus Global safety database and data output
• In-depth knowledge of US and ICH safety reporting regulations and guidelines
• Proficiency in conducting internal audits, partner audits, risk assessments, and compliance monitoring activities
• Strong working skills in MS Word, Excel, and PowerPoint, including statistical analysis
• Excellent understanding of medical concepts and medical terminology
• Proficient in both written and spoken English, with excellent written and verbal communication skills to interact across multiple functions
• Attention to detail with strong scientific, analytical, and conceptual skills, enabling the ability to reach reasoned conclusions
• Ability to work independently, manage multiple priorities, and adapt to changing demands in a fast-paced environment. Must meet internal and external deadlines
• Strong organizational abilities
• Self-motivation and the ability to work collaboratively as a team member are essential
• Certification in pharmacovigilance (e.g., RQAP-GLP, PVQA) or quality management (e.g., ASQ Certified Quality Auditor) is a plus