Pharmacovigilance Compliance and Oversight Manager

Galderma

Pharmacovigilance Compliance and Oversight Manager responsible for overseeing PV quality management systems. Ensures compliance with U.S.

Posted 4/28/2026full-timeBoston • Massachusetts, Texas • 🇺🇸 United StatesMid-LevelSenior💰 $130,000 - $180,000 per yearWebsite

About the role

Key responsibilities & impact

Overseeing and maintaining the local PV quality management system (QMS) to ensure compliance with applicable U.S. and global pharmacovigilance regulations.
Providing an independent quality and compliance perspective across PV activities, supporting inspection readiness, CAPA management, compliance monitoring, and continuous improvement initiatives.
Establishing, maintaining, and continuously enhancing the local PV Quality Management System in alignment with global PV standards and regulatory requirements.
Owning PV quality documentation governance, including SOP frameworks, work instructions, local addenda, document control, and archival processes.
Conducting ongoing compliance monitoring of PV systems, processes, and activities to assess adherence to regulatory and internal requirements.
Tracking, trending, and reporting PV quality and compliance metrics to PV leadership.
Managing PV quality events, including deviation investigations, root cause analysis, CAPA development, effectiveness verification, and closure.
Coordinating audit and inspection readiness activities, including documentation preparation, mock inspections, and tracking of inspection outcomes.
Supporting regulatory change impact assessments and ensuring timely updates to SOPs, training materials, and quality documentation.
Collaborating with Global PV Compliance, Quality Assurance, and cross‑functional partners to align oversight activities and remediation efforts.
Ensuring PV training requirements are defined, current, and audit‑ready; supporting delivery of compliance‑focused training as needed.

Requirements

What you’ll need

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.

Benefits

Comp & perks

health insurance
401(k) plan with employer match
a generous paid time off policy
hybrid work schedules
annual short-term incentive program based on corporate performance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilancequality management systemCAPA managementcompliance monitoringdeviation investigationsroot cause analysisregulatory inspection supportsafety reporting processescompliance assessmentstrend analyses

Soft Skills

organizational skillsanalytical skillsproject management skillscommunication skillscollaboration skillsindependenceability to manage multiple priorities

Certifications

advanced degreeMaster’sPharmDMDPhD