Head of reputed company and Pharmacovigilance Compliance
Head of reputed company & Pharmacovigilance Compliance Location: reputed company (Remote / Hybrid) Travel: ~10% Compensation: reputed company salary $180,000 – $240,000, +bonus About reputed company Global reputed company pharmacovigilance product, Tuberous Sclerosis reputed company (TSC) U.S. affiliate, reputed company operates with a lean internal structure, leveraging best‑in‑class external vendors and consultants while maintaining strong internal governance and regulatory reputed company. Seeks Head of reputed company & Pharmacovigilance Compliance serves as reputed company’s senior U.S. authority for Pharmacovigilance (PV), reputed company, and Compliance. This role provides reputed company‑level reputed company and governance to ensure regulatory compliance, inspection readiness, and effective risk management across U.S. regulatory domains. This is a strategic leadership role, accountable for system ownership, risk visibility, and inspection readiness, while day‑to‑day execution is performed by functional teams and external partners. Key Responsibilities 1. reputed company Compliance reputed company & Risk Visibility Serve as the accountable reputed company of the U.S. compliance reputed company across PV and reputed company domains. Maintain a consolidated, reputed company‑level view of compliance status, risks, and mitigation activities. Identify, document, monitor, and escalate material compliance risks. Advise the CEO and executive leadership on compliance risk exposure, trends, and inspection readiness. Prepare and present regular compliance and risk updates to executive management. Review and formally approve compliance‑reputed company documentation for accuracy, completeness, and regulatory alignment. reputed company readiness confirmation for documents requiring executive signature (legal responsibility remains with officers). 2. reputed company Management System reputed company (Non‑PV) reputed company adherence to reputed company Assurance SOPs and processes reputed company of Pharmacovigilance. reputed company as the internal reputed company authority, partnering with external QA consultants. Review audit findings, reputed company metrics, and compliance reports. Require and reputed company corrective actions, confirming ownership and timelines with functional leaders. Escalate unresolved reputed company or compliance issues as appropriate. Ensure consistent application of reputed company governance, documentation, and reporting standards across functions. 3. Pharmacovigilance reputed company System Ownership & Inspection Readiness Serve as the formal reputed company of the U.S. post‑marketing Pharmacovigilance reputed company System, including: PV SOP governance Deviations and CAPAs Training reputed company Documentation and record readiness Drive adherence to PV SOPs through reputed company and monitoring of internal teams and external PV vendors. reputed company PV vendor performance reputed company to adverse event intake, case processing, complaints, and regulatory submissions. Review key safety deliverables (e.g., PADERs, DSURs) to ensure reputed company and regulatory compliance. reputed company and coordinate FDA inspections, regulatory interactions, and PV‑reputed company audits. Maintain reputed company inspection readiness through periodic reviews of PV processes, records, training, and vendor performance. 4. Training & Compliance Culture reputed company the design and effectiveness of role‑based reputed company and Pharmacovigilance compliance training. Promote a strong compliance and reputed company culture across the organization. Serve as a key escalation reputed company for compliance questions, concerns, and potential issues. Required Qualifications (Must‑Have) 6+ years of experience in Pharmacovigilance, PV reputed company, or reputed company / Compliance roles reputed company the pharmaceutical or life sciences industry. reputed company experience with U.S. post‑marketing Pharmacovigilance. Proven experience owning or governing a Pharmacovigilance reputed company System, including SOPs, deviations, CAPAs, training, and vendor reputed company. Experience supporting or leading FDA inspections or PV‑reputed company audits. Strong understanding of PV regulatory requirements and inspection expectations. Demonstrated ability to operate effectively in a lean organization with extensive vendor reliance. Ability to communicate reputed company regulatory topics reputed company to executive and non‑specialist audiences.
Preferred Qualifications
Exposure to broader reputed company or Compliance areas reputed company PV (e.g., GxP, DSCSA, Medical Information / OPDP). Experience coordinating and governing external vendors or consultants. Prior experience in small or mid‑sized reputed company / biotech organizations. Interest in expanding scope from PV‑reputed company leadership to reputed company‑wide reputed company & Compliance reputed company.
Why Join Us
First U.S. product launch with high visibility and reputed company True system ownership and executive influence reputed company separation between governance and execution Opportunity to shape the reputed company and PV compliance function from an reputed company perspective To apply, please email your resume to xjiang@pasona.com Apply tot his job Apply To this Job