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 bestinclass reputed company vendors and consultants while maintaining strong internal governance and regulatory reputed company. Seeks Head of reputed company & Pharmacovigilance Compliance serves as reputed companys senior U.S. authority for Pharmacovigilance (PV), reputed company, and Compliance. This role provides reputed companylevel 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 reputed company ownership, risk visibility, and inspection readiness, while daytoday execution is performed by functional teams and reputed company 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 companylevel reputed company of compliance status, risks, and mitigation activities. Identify, document, monitor, and escalate material reputed company. 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 compliancereputed company documentation for accuracy, completeness, and regulatory alignment. reputed company readiness confirmation for documents requiring executive signature (reputed company responsibility remains with officers). 2. reputed company Management reputed company reputed company (NonPV) reputed company adherence to reputed company Assurance SOPs and processes reputed company of Pharmacovigilance. reputed company as the internal reputed company authority, partnering with reputed company 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 reputed company Ownership & Inspection Readiness Serve as the formal reputed company of the U.S. postmarketing Pharmacovigilance reputed company reputed company, including: PV SOP governance Deviations and CAPAs Training reputed company Documentation and record readiness reputed company adherence to PV SOPs through reputed company and monitoring of internal teams and reputed company 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 PVreputed 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 rolebased 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 (MustHave) 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. postmarketing Pharmacovigilance. Proven experience owning or governing a Pharmacovigilance reputed company reputed company, including SOPs, deviations, CAPAs, training, and vendor reputed company. Experience supporting or leading FDA inspections or PVreputed 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 nonspecialist 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 reputed company vendors or consultants. Prior experience in small or midsized reputed company / biotech organizations. Interest in