Ardelyx, Inc.
Ardelyx is a biopharmaceutical company focused on creating first-in-class medicines to meet unmet medical needs. The company specializes in therapeutic areas such as chronic kidney disease with hyperphosphatemia and irritable bowel syndrome with constipation (IBS-C). Ardelyx is committed to patient care, innovation, and collaboration with the community, aiming to improve quality of life for patients through novel treatments. With core values of fearlessness, passion, dedication, and inclusivity, Ardelyx fosters a respectful and inclusive workplace. The company is engaged in clinical trials and partnerships to support its mission of patient-centered medical advancement.
Associate Director - Pharmacovigilance
March 7
Ardelyx, Inc.
Ardelyx is a biopharmaceutical company focused on creating first-in-class medicines to meet unmet medical needs. The company specializes in therapeutic areas such as chronic kidney disease with hyperphosphatemia and irritable bowel syndrome with constipation (IBS-C). Ardelyx is committed to patient care, innovation, and collaboration with the community, aiming to improve quality of life for patients through novel treatments. With core values of fearlessness, passion, dedication, and inclusivity, Ardelyx fosters a respectful and inclusive workplace. The company is engaged in clinical trials and partnerships to support its mission of patient-centered medical advancement.
📋 Description
• Responsible for ensuring adherence of pharmacovigilance activities to regulatory requirements • Manage vendor supervision, case processing, aggregate reports, and audits • Ensure compliance with regulatory standards • Collect, analyze, and provide adverse event data • Oversee regulatory submissions for ICSRs from the Global Safety database • Collaborate with cross-functional teams to address quality and compliance-related issues • Stay updated on changes in pharmacovigilance regulations and industry trends • Contribute to process improvement initiatives
🎯 Requirements
• Bachelor’s degree in Life Sciences • 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 • 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 • Excellent understanding of medical concepts and medical terminology • Proficient in both written and spoken English • Attention to detail with strong scientific, analytical, and conceptual skills • Ability to work independently, manage multiple priorities, and adapt to changing demands • Strong organizational abilities • Self-motivation and the ability to work collaboratively as a team member • Certification in pharmacovigilance or quality management is a plus
🏖️ Benefits
• 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 • At least 11 paid holidays
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