Job Description

Position Summary

This pivotal leadership role requires a visionary with significant expertise in pharmacovigilance, regulatory compliance, and risk management strategies. The successful candidate will be responsible for setting the strategic direction and ensuring the operational effectiveness of the drug safety and pharmacovigilance group. This includes championing excellence in drug safety practices, overseeing global safety surveillance programs, and acting as the principal pharmacovigilance contact for cross-functional teams, regulatory agencies, and external partners.

Responsibilities

• Direct the handling of adverse events according to national and international regulatory reporting requirements and ensure timely, complete, and accurate submission of Individual Case safety reports to regulatory authorities in compliance with regulations
• As our Phase 3 oversight lead, collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and quality assurance, to ensure that all safety data is accurately collected, analyzed, and reported in compliance with applicable regulations
• Accountable for the oversight of the operational activities with the PV vendors and Service Providers including the establishment of adequate standards/processes and tracking of the performance.
• Lead or assist in continuous safety data assessments to identify trends or concerns. Partner with clinical scientists, study managers, data teams, and statisticians to interpret findings and compile interim and final study reports.
• Accountable for approval of cross functional document review such as CCGs, blinding plan, case report forms, TMF plans and reconciliation documents
• Assist in the preparation and evaluation of regulatory filings (e.g., INDs, DSURs, REMS, BLA, NDAs), including addressing safety-related inquiries from regulatory agencies. Contribute to safety narratives and strategic input for briefing materials and regulatory meetings
• Prepare and maintain drug safety departmental policies that address the processing, analysis and reporting of safety information to ensure proactive surveillance of compounds across life cycle
• Manage both the operations and safety science line functions. Actively mentor PV staff and contribute to the development and rapid growth of a state-of-the art PV department. Strategize upcoming deliverables, delegating tasks as necessary to team members and support the team during high volume periods by contributing to resolving workload demands
• Support internal audits and regulatory inspections
• Represent pharmacovigilance in cross-team and operational meetings

Qualifications

• Undergraduate degree, MS preferred with a minimum of 10 years' experience in the pharma/biotech industry. Broad clinical trial experience is required with deep knowledge in leading regulatory submissions.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate (verbally and in writing) complex clinical/pharmaceutical information and safety data.
• Proficiency inArgus, ArisG or similar database, proficiency in MedDRA and WhoDrug
• Experience with US/ex-US safety reporting requirements

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Job Tags

Full time, Interim role, Visa sponsorship, Work visa,

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