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PharmaEssentia · 1 day ago

Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

Burlington, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$150K/yr - $200K/yr

8+ years exp

PharmaEssentia USA is a rapidly growing biopharmaceutical innovator focused on delivering effective new biologics for challenging diseases. The Associate Director of Pharmacovigilance Quality & Compliance will ensure adherence to global regulatory standards and oversee the development and maintenance of the PV Quality Management System while managing audits and driving process improvements.

BiotechnologyHealth CarePharmaceutical

Growth Opportunities

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

Qualification

PharmacovigilanceQuality Management SystemGlobal PV regulationsSOP developmentLeadershipCommunication skillsProblem-solving skillsCross-functional collaboration