Director, Pharmacovigilance Operations & Compliance

Altimmune; Morristown (NJ); Ibrido; USD 180.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Regulatory compliance training

Descrizione del lavoro

Altimmune seeks a Director of Pharmacovigilance Operations to oversee the PV system and ensure compliance with regulatory requirements and partner obligations. This role manages vendors, inspection readiness, quality oversight, and governance processes across PV activities, partnering with Regulatory Affairs, QA, Medical Affairs, Commercial, Clinical, and external service providers.

Depending on location, the role may be hybrid or remote.

Competenze

• Bachelor's degree in science or health field with pharmaceutical industry background.
• 10+ years in Drug Safety/PV operations in biotech.
• Experience with vendor oversight, PV Agreements, compliance monitoring, inspection readiness.
• Knowledge of FDA, ICH and global PV requirements.
• Experience supporting FDA inspections.
• Deep PV science knowledge and regulatory oversight.
• Strong analytical, communication, organizational and project management skills.

Mansioni

• Oversee global PV activities including case processing, reporting, literature surveillance and safety data reconciliations.
• Monitor PV performance metrics and quality indicators; track trends and compliance.
• Identify, investigate and escalate PV compliance issues.
• Govern vendor oversight for PV vendors, CROs, license partners and other external parties; manage contracts and oversight.
• Coordinate inspection readiness activities for FDA/Health Canada and partners.
• Lead PV governance meetings and cross-functional safety deliverables and timelines.

Conoscenze

Analytical skills

Communication skills

Organizational skills

Project management

Leadership

Cross-functional collaboration

Formazione

Bachelor's degree in science/health

Descrizione del lavoro

Altimmune seeks a Director of Pharmacovigilance Operations to oversee the PV system and ensure compliance with regulatory requirements and partner obligations. This role manages vendors, inspection readiness, quality oversight, and governance processes across PV activities, partnering with Regulatory Affairs, QA, Medical Affairs, Commercial, Clinical, and external service providers.

Depending on location, the role may be hybrid or remote.