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 approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

POSITION SUMMARY:

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.
In this role, you will be responsible for ensuring the highest quality of pharmacovigilance operations and safety outputs and analysis in compliance with global regulations and standards. The ideal candidate for this position should possess experience in the pharmaceutical industry and safety and pharmacovigilance, along with a demonstrated track record of success in safety surveillance, data analysis, aggregate reports. You should have excellent organizational, analytical, and problem-solving skills, as well as the ability to work collaboratively with all levels of the organization.

QUALIFICATIONS:

• Bachelor’s degree in Life Sciences, Master’s degree is a plus, with 8 – 10 years of experience in drug safety/pharmacovigilance within the pharmaceutical or biotech industry or equivalent experience
• 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 participating in 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
  The anticipated annualized base pay range for this full-time position is $180,000-$220,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
  Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
  Ardelyx is an equal opportunity employer

• 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
• Support the PV in coordinating medical-scientific monitoring and assessing the safety profile of one or more Ardelyx products
• Prepare Pharmacovigilance meeting materials/presentations for cross-functional safety meetings
• Lead and contribute as necessary applying knowledge of safety, regulatory science, and signal surveillance to manage characterization of the compound/product safety benefit-risk profile.
• Provide assistance in the Pharmacovigilance development of the initial safety surveillance development strategy and leading subsequent updates to this strategy.
• Perform the first level safety signal detection and signal evaluation activities (e.g., safety database and literature review, health authority queries) for Astellas products, and finalizing these assessments in conjunction with the Safety Surveillance Team
• 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
• Provide partnership in the 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
• 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 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