Associate Director, Pharmacovigilance Quality & Compliance (PVQA)
PharmaEssentiaUnited States
Posted November 6, 2025
150000 - 200000 USD year
Full Time
About the Company
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation, is a global biopharmaceutical innovator specializing in the development and delivery of new biologics for hematology, oncology, and immunology. With a focus on rare diseases and orphan drugs, the company leverages deep expertise and proven scientific principles to advance drug development. Founded in 2003, PharmaEssentia has expanded its global presence across the U.S., Japan, China, and Korea.
Job Description
The Pharmacovigilance (PV) Quality and Compliance Associate Director will be responsible for ensuring Pharmacovigilance activities adhere to global regulatory standards and quality expectations across all safety activities. This role oversees the development and maintenance of the PV Quality Management System (QMS), manages audits and inspections, and drives continuous process improvement to enhance compliance and efficiency.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- Minimum 8–10 years of experience in pharmacovigilance, with at least 3–5 years in PV quality and compliance.
- Strong knowledge of global PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP).
- Proven experience leading PV audits and inspections.
- Demonstrated ability to develop and implement quality management systems and SOPs.
- Excellent leadership, communication, and problem-solving skills.
- Ability to influence cross-functional teams and drive compliance initiatives.
Benefits
- Comprehensive medical coverage
- Dental and vision coverage
- Generous paid time-off
- 401(k) retirement plan with competitive company match
- Medical & Dependent Care Flexible Spending Account
- Up to $150 monthly cell phone reimbursement
- Employee Assistance Program
- Free parking
