Pharmacovigilance Compliance and Oversight Manager

Galderma•Boston, MA

1d•Hybrid

About The Position

The Pharmacovigilance (PV) Compliance and Oversight Manager, U.S. Region is responsible for overseeing and maintaining the local PV quality management system (QMS) to ensure compliance with applicable U.S. and global pharmacovigilance regulations, company policies, and industry standards. The role provides an independent quality and compliance perspective across PV activities, supporting inspection readiness, CAPA management, compliance monitoring, and continuous improvement initiatives. This position partners closely with the Local Safety Officer (LSO), Senior PV Manager, and Global PV Compliance and Quality teams. While strategic regulatory engagement is led by PV leadership, the PV Compliance and Oversight Manager is responsible for operational oversight, documentation, monitoring, and quality execution within the affiliate.

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, including FDA requirements, ICH guidelines, and GVP modules.
Strong understanding of PV systems, safety reporting processes, and quality oversight best practices.
Proven ability to conduct compliance assessments, root cause analyses, risk evaluations, and trend analyses.
Experience supporting regulatory inspections and internal audits.
Strong organizational, analytical, and project management skills with the ability to manage multiple priorities.
Excellent written and verbal communication skills, including presentation of compliance metrics and quality findings to leadership.
Ability to work independently in a matrix environment and collaborate effectively with global and local stakeholders.
High attention to detail and strong commitment to data integrity and compliance.

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 (e.g., KPIs, QPIs, deviations, CAPAs, 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.
Collaborates with Global PV Compliance, Quality Assurance, and cross‑functional partners to align oversight activities and remediation efforts.
Ensures PV training requirements are defined, current, and audit‑ready; supports delivery of compliance‑focused training as needed.
Identifies compliance risks, quality trends, and opportunities for continuous improvement and escalates issues appropriately.
Contributes to PV system enhancements, inspections readiness planning, and quality initiatives supporting regulatory compliance and operational excellence.