Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

PharmaEssentia U.S.A.•Burlington, MA

63d•$150,000 - $200,000

About The Position

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. Acting as a key liaison between internal teams and external vendors, the PV Quality and Compliance Associate Director provides expert guidance on SOPs, CAPAs, and inspection readiness, while monitoring risks and quality metrics with our CRO’s and within pharmacovigilance for PharmaEssentia. The ideal candidate brings deep knowledge of global PV regulations, strong leadership, and the ability to foster collaboration across functions to uphold the highest standards of patient safety and regulatory compliance.

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.

Responsibilities

Lead the development and maintenance of the PV Quality Management System (QMS).
Ensure compliance with global regulatory requirements (FDA, EMA, MHRA) and ICH-GCP/ICH-E2E guidelines.
Oversee PV audits, inspections, and readiness activities with PV vendors.
Collaborate with CRO vendor, QA, Regulatory, and Clinical teams to implement corrective and preventive actions (CAPAs).
Develop, review, and approve Standard Operating Procedures (SOPs) and work instructions for PV activities.
Build/maintain an inspection readiness program to detect potential gaps and monitor CPA Effectiveness.
Ensure process standardization across global PV operations.
Drive continuous improvement initiatives to enhance efficiency and compliance with vendors and internally.
Ensure high quality ICSR on time management
Track and interpret changes in regulations within Pharmacovigilance landscape
Works with responsible person/team to author a required regulatory response.
Monitor key quality and compliance metrics, identify risks, and recommend mitigation strategies.
Conduct internal and external vendor quality reviews and gap assessments r/t safety.
Support global safety reporting quality oversight.
Provide guidance and training to PV staff on quality standards and compliance expectations.
Serve as a subject matter expert for inspections, regulatory audits, and PV compliance matters.
Cross functional collaboration with Call center, supply chain, Manufacturing (QA) and US QA teams to oversee any quality issues that may arise that involve PSRM
Collaborate with cross-functional teams (Clinical, Regulatory, Medical Affairs, and Operations) to maintain high-quality safety processes.