Pharmacovigilance Compliance and Oversight Manager

1w1 week ago

Galderma

Boston, US · Full-time · $130,000 – $180,000

About this role

Galderma provides a unique breadth of integrated offerings covering Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology products. The Pharmacovigilance Compliance and Oversight Manager, U.S. Region oversees and maintains the local PV quality management system for compliance with U.S. and global regulations, company policies, and industry standards. This role delivers an independent quality perspective across PV activities, supporting inspection readiness and continuous improvement.

The position involves establishing, maintaining, and enhancing the local PV Quality Management System aligned with global standards. It owns PV quality documentation governance, including SOP frameworks, work instructions, and local addenda. Daily tasks include conducting compliance monitoring, managing deviations and CAPAs, and tracking quality metrics.

This role partners closely with the Local Safety Officer, Senior PV Manager, and Global PV Compliance and Quality teams. It coordinates audit and inspection readiness, supports regulatory change assessments, and collaborates with Quality Assurance and cross-functional partners. Operational oversight ensures documentation, monitoring, and quality execution within the affiliate.

Galderma gives teams reasons to believe in its ambition to become the world's leading dermatology company. Employees gain new and challenging work experiences with unparalleled direct impact. The role contributes to PV system enhancements, risk identification, and quality initiatives for regulatory compliance and operational excellence.

Requirements

Advanced degree (Master’s, PharmD, MD, PhD) in life sciences, pharmacy, medicine, or a related field required
6+ years of experience in pharmacovigilance quality, compliance, or safety operations within the pharmaceutical, biotechnology, or medical device industry
Demonstrated experience with PV quality systems, deviation and CAPA management, and regulatory inspection support
In-depth knowledge of U.S. and international PV regulations
Experience owning PV quality documentation governance and SOP frameworks
Proficiency in compliance monitoring, metrics tracking, and quality event management
Ability to conduct root cause analysis and support audit/inspection readiness

Responsibilities

Establishes, maintains, and continuously enhances the local PV Quality Management System in alignment with global PV standards and regulatory requirements
Owns PV quality documentation governance, including SOP frameworks, work instructions, local addenda, document control, and archival processes
Authors and maintains compliance-specific procedures related to deviations, CAPAs, compliance monitoring, and inspection readiness
Conducts ongoing compliance monitoring of PV systems, processes, and activities to assess adherence to regulatory and internal requirements
Tracks, trends, and reports PV quality and compliance metrics including KPIs, QPIs, deviations, CAPAs, and audit findings to PV leadership
Manages PV quality events, including deviation investigations, root cause analysis, CAPA development, effectiveness verification, and closure
Coordinates audit and inspection readiness activities, including documentation preparation, mock inspections, and tracking of inspection outcomes
Supports regulatory change impact assessments and ensures timely updates to SOPs, training materials, and quality documentation

Benefits

Unique breadth of integrated offering covering Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology products
Commitment to recognizing and rewarding people for their contributions
Opportunity to gain new and challenging work experiences
Unparalleled direct impact on becoming the leading dermatology company in the world