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Associate Director, Pharmacovigilance

7+ years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, Pharmacovigilance
Location: [Location]
Job Category: Pharmacovigilance


Company Overview:

Ardelyx is a publicly traded biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines that address significant unmet medical needs. With two commercial products approved in the United States—IBSRELA® (tenapanor) and XPHOZAH® (tenapanor)—Ardelyx is making a global impact. The company has partnerships for the development and commercialization of tenapanor in regions outside of the U.S. including Kyowa Kirin in Japan and Fosun Pharma in China. Knight Therapeutics also commercializes IBSRELA in Canada.


Purpose of the Role:

Ardelyx is seeking a highly motivated and experienced Associate Director, Pharmacovigilance to join our team. As a subject matter expert, you will be responsible for ensuring compliance with global regulations, industry standards, and company policies in the pharmacovigilance (PV) field. Your role will be critical in overseeing pharmacovigilance operations, ensuring the quality of safety data, and contributing to continuous improvement initiatives.


Key Responsibilities:

  • Regulatory Compliance: Ensure timely and accurate safety data outputs to regulatory agencies and internal stakeholders, in line with global regulations.
  • Data Collection & Analysis: Analyze adverse event data from clinical trials and post-market surveillance, generating accurate reports for stakeholders.
  • Vendor Management: Serve as the primary liaison for pharmacovigilance vendors, ensuring contract compliance, quality, and timeliness of deliverables.
  • Safety Oversight: Perform oversight of safety vendors, ensuring efficient, consistent, and compliant pharmacovigilance activities with minimal supervision.
  • Regulatory Submissions: Oversee regulatory submissions for adverse event reports and communicate with global health authorities and business partners.
  • Audit & Compliance: Lead internal audits and regulatory inspections for all pharmacovigilance processes and systems.
  • Cross-functional Collaboration: Work with various departments such as Regulatory Affairs, Quality Assurance, Medical Affairs, and IT to address quality and compliance issues.
  • Process Improvement: Contribute to process improvement initiatives for aggregate reporting, clinical trial safety, and signal management.
  • Training & SOP Development: Provide guidance in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment.
  • Regulatory Updates: Stay updated on pharmacovigilance regulations, guidelines, and industry trends to ensure ongoing compliance.

Qualifications:

  • Educational Requirements: Bachelor’s degree in Life Sciences (Master’s degree preferred).
  • Experience: 8-10 years of experience in drug safety/pharmacovigilance, quality assurance, or compliance within the pharmaceutical or biotech industry.
  • Technical Skills: Experience with pharmacovigilance databases (preferably Argus Global safety database), proficiency in MS Word, Excel, and PowerPoint, including statistical analysis.
  • Regulatory Knowledge: In-depth knowledge of U.S. and ICH safety reporting regulations and guidelines.
  • Audit Skills: Experience conducting internal and partner audits, risk assessments, and compliance monitoring activities.
  • Communication Skills: Strong written and verbal communication skills in English to interact across multiple functions.
  • Attention to Detail: Strong scientific, analytical, and conceptual skills, with the ability to reach reasoned conclusions.
  • Certifications: Certification in pharmacovigilance (e.g., RQAP-GLP, PVQA) or quality management (e.g., ASQ Certified Quality Auditor) is a plus.

Compensation & Benefits:

  • Base Pay Range: $180,000 - $220,000 annually. Actual base pay will be determined based on factors such as experience, qualifications, and internal equity.
  • Incentives: Includes an annual bonus target and equity awards, subject to eligibility.
  • Benefits Package: Includes 401(k) with employer match, paid parental leave, living organ and bone marrow leave, health plans (medical, dental, vision), life insurance, disability, flexible time off, and at least 11 paid holidays.

Equal Opportunity Employer:

Ardelyx is an equal opportunity employer, committed to creating a diverse and inclusive work environment. We encourage all qualified individuals to apply, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.