Director, PV Operations & Compliance (Remote)

TerSera Therapeutics LLC; Deerfield (IL); Hybrid; USD 180,000 - 240,000; Full time

Job summary

TerSera Therapeutics LLC is seeking a Director of Pharmacovigilance Operations to oversee the PV system, ensure compliant delegated activities, and lead governance across vendors and partners. The role collaborates with Regulatory Affairs, Quality Assurance, Medical Affairs, and external service providers to maintain inspection readiness.

The position reports to the VP of Pharmacovigilance, with potential for remote, hybrid, or Deerfield, IL headquarters-based work arrangements.

Qualifications

• Demonstrated experience with vendor oversight, PV agreements, compliance monitoring, inspection readiness, regulatory reporting requirements.
• Knowledge of FDA, Health Canada, ICH, and global pharmacovigilance requirements.
• Experience supporting FDA and Health Canada inspections.
• Experience in specialty pharmaceutical/biotech pharmacovigilance environments.

Responsibilities

• Provide day-to-day oversight of the PV system and delegated PV activities to ensure compliance.
• Serve as operational governance lead for vendor and partner oversight.
• Coordinate inspection readiness activities and support regulatory inspections.
• Maintain PV quality framework and oversee CAPAs, audits, and evidence retrieval.
• Lead PV training governance and governance documentation.

Skills

Vendor oversight

PV Agreements

Compliance monitoring

Inspection readiness

Quality systems

CAPA management

Regulatory reporting

Risk management

Education

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree

Job description

TerSera Therapeutics LLC is seeking a Director of Pharmacovigilance Operations to oversee the PV system, ensure compliant delegated activities, and lead governance across vendors and partners. The role collaborates with Regulatory Affairs, Quality Assurance, Medical Affairs, and external service providers to maintain inspection readiness.

The position reports to the VP of Pharmacovigilance, with potential for remote, hybrid, or Deerfield, IL headquarters-based work arrangements.