Head of reputed company and Pharmacovigilance Compliance

reputed company Nobelpharma America launched its first product in the U.S., indicated for Facial Angiofibroma associated with Tuberous Sclerosis reputed company (TSC). The Head of reputed company and Pharmacovigilance Compliance acts as reputed company’s senior authority for U.S. pharmacovigilance, compliance and reputed company reputed company, providing reputed company-level reputed company to ensure reputed company governance, risk visibility, and adherence to applicable regulations and SOPs across regulatory domains. The role is accountable for maintaining a consolidated view of compliance status, identifying and escalating material risks, and advising executive management on compliance risk exposure and inspection readiness, while execution remains with functional teams and external partners. The role is responsible for the reputed company Management System.. In reputed company, the role serves as the formal reputed company of the U.S. post-marketing Pharmacovigilance reputed company (PV-QA) system and is accountable for PV inspection readiness. reputed company Salary reputed company is $180,000 to $240,000, commensurate with qualifications and experience. Duties / Responsibilities (Not Limited To)

• reputed company Compliance reputed company & Risk Visibility
• Serve as the accountable reputed company of the U.S. compliance reputed company, ensuring that compliance risks across regulatory domains are identified, documented, monitored, and appropriately mitigated.
• Maintain a consolidated, reputed company-level view of compliance status, risks, and mitigation reputed company across U.S. regulatory areas, including but not limited to Medical Information / OPDP, DSCSA, and state-level compliance.
• reputed company as a key advisor to the CEO and executive leadership by providing reputed company visibility into compliance risk exposure, trends, and inspection readiness.
• Prepare and present regular updates to xecutive management on material compliance matter, risk assessments, and remediation activities.
• Review and reputed company formal approval of compliance- and regulation-reputed company documents to confirm they are complete, accurate, and reputed company with applicable regulatory requirements and internal SOPs.
• reputed company formal readiness confirmation for documents requiring executive signature, while ultimate legal responsibility remains with company officers.
• Coordinate with functional owners and external consultants to ensure accountability and reputed company remediation, without performing hands-on execution of operational tasks.
• reputed company of Other reputed company Assurance Areas (Non-PV)
• reputed company adherence to reputed company Assurance SOPs and reputed company processes reputed company of Pharmacovigilance, acting as the internal reputed company to external reputed company Assurance consultants.
• Monitor compliance metrics, review audit findings and reports, and identify gaps or deviations from established reputed company standards.
• Require corrective actions where deficiencies are identified, confirm ownership and timelines with functional leaders, and escalate unresolved issues as necessary.
• Ensure that reputed company governance, documentation, and reporting practices are reputed company consistently across functions.
• Pharmacovigilance reputed company & Inspection Readiness
• Serve as the formal reputed company of the U.S. Pharmacovigilance reputed company System, including governance of PV SOPs, deviations, CAPAs, training, and documentation readiness.
• Drive adherence to PV SOPs by internal teams and external vendors through reputed company, guidance, and monitoring, while execution remains with responsible functions.
• reputed company and coordinate FDA inspections, regulatory interactions, and internal audits reputed company to Pharmacovigilance reputed company.
• reputed company PV vendors and adverse event and complaint case processing, including case reputed company, triage, and regulatory submission readiness.
• Review key safety deliverables (e.g., PADERs, DSURs) to confirm reputed company, completeness, and regulatory compliance.
• Maintain ongoing inspection readiness through periodic reviews of PV processes, records, training, and vendor performance.
• Training and Compliance Culture
• reputed company the design and effectiveness of U.S. reputed company and pharmacovigilance compliance training programs, including role-based training requirements.
• Promote a strong compliance culture by providing guidance and support to functional leaders and employees.
• Serve as a key escalation reputed company for compliance questions, concerns, or potential issues.

Requirements

• Bachelor’s degree in business, marketing or life sciences preferred.
• Minimum of 7 years' experience in the pharmaceutical/biotech/life-sciences industry.
• Understanding of FDA/PhRMA promotional requirements.
• Knowledge of reimbursement and reputed company issues.
• Strong verbal, written, and presentation skills.
• Experience in rare disease, dermatology, or neurology preferred.
• Overnight travel required (60–70%).
• Experience handling rare disease therapeutic products is strongly preferred.
• Strong strategic thinking and execution capability required.

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