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.
Purpose of the role:
We are seeking a highly motivated, experienced, and passionate individual to join our team as Pharmacovigilance Quality and Compliance Pharmacovigilance Coordinator at Ardelyx Inc. As a subject matter expert, you will play a pivotal role in ensuring the adherence of our pharmacovigilance 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 in compliance with global regulations and standards. The ideal candidate for this position should possess several years of experience in the pharmaceutical industry and pharmacovigilance, along with a demonstrated track record of success in managing quality assurance systems and audits. You should have excellent organizational, analytical, and problem-solving skills, as well as the ability to work collaboratively with all levels of the organization. Appropriately perform all quality and compliance related activities with appropriate oversight.
Position Responsibilities:
- 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.
- 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.
- 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.
- Document observations, deviations, non-conformities, and areas for improvement identified during audits.
- Utilize checklists, questionnaires, and other tools to systematically assess compliance with regulatory requirements and internal standards.
- 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.
- Manage data clean-up and migration from vendor safety databases.
- Provide guidance and support in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment and best practices.
- Support compilation, maintenance, and ongoing reviews of the Pharmacovigilance System Master File (PSMF).
- Prepare pharmacovigilance reports, presentations, and documentation for management reviews, regulatory submissions, and health authority inspections/audits.
- Stay updated on changes in pharmacovigilance regulations, guidelines, and industry trends to ensure ongoing compliance and proactively address emerging requirements.
- Provide training and guidance to pharmacovigilance staff and stakeholders on compliance-related topics, including adverse event reporting, signal detection, and regulatory 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.
- Perform routine follow-up and timely reporting/submission of safety information from various sources, adhering to SOPs and regulatory requirements.
- Determine follow-up actions and generate appropriate letters/queries via email or phone contact.
- Monitor Key Performance Indicators for the PV system and ensure global PV system compliance.
- Support PV audit and inspection preparation.
- Undertake other activities as needed or as requested by the supervisor.
Position Requirements:
- Master's degree in healthcare, life science degree, or a related field is required.
- Minimum of 6 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.
- 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.
The anticipated annualized base pay range for this full-time position is $85,500-$104,500. 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 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.
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Ardelyx
life insurance, parental leave, paid holidays, flex time, 401(k)
Dec 22, 2024