Medical Director, Pharmacovigilance

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.

• Serve as Global Safety Lead (GSL) and the safety expert for assigned pharmaceutical products, accountable for the safety strategy and major safety deliverables for each assigned product
• Lead the Safety Management Team (SMT) for assigned compounds and products and represents the cross functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders
• Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature for assessment of benefit-risk profile and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products
• Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products
• Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees
• Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, and CTAs) in collaboration with cross-functional colleagues
• Provide patient safety input to the clinical development program for assigned products and development compounds, and represent PV on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable
• Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Biometrics, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal
• Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents
• Up to 10% of domestic travel to attend meetings

• Doctor of Medicine (M.D.) with 8+ years of pharmacovigilance, drug safety, or related experience or equivalent experience
• Extensive experience in evaluating signal detection activities and analyzing safety data, identify trends, and detect new or emerging safety signals
• Ability to analyze using statistical methodologies (e.g., disproportionality analysis) to assess potential safety concerns and evaluate the frequency and severity of adverse events
• Proven strategic mindset to analyze information to strategize, recommend, and develop risk management plans
• Advanced analytical skills to evaluate and develop periodic safety reports, including Periodic Benefit Risk Evaluation Reports (PBRER), Developmental Safety Update Reports (DSURs), and Periodic Adverse Drug Experience Reports
• Proven ability to utilize MedDRA and assign appropriate MedDRA terms to describe adverse events and WHO DD dictionary coding to accurately capture and standardize information related to medicinal products
• Experienced in designing and implementing strategic, safety and personnel development as required