Senior Pharmacovigilance Manager

Senior Pharmacovigilance Manager

The Senior Pharmacovigilance (PV) Manager reports to the Local Safety Officer (LSO) and serves as the designated Deputy LSO for the U.S. affiliate. This senior leadership role is responsible for providing strategic and operational oversight of the local pharmacovigilance system and for assuming LSO accountability as delegated or in the LSO's absence.

The role leads day?to?day PV operations, including safety surveillance, signal detection, risk management, periodic reporting, vendor oversight, patient support program safety, and inspection readiness. The Senior PV Manager partners closely with Global Pharmacovigilance, PV Compliance and Oversight, and cross?functional stakeholders to ensure a compliant, high?performing U.S. PV system.

Key Responsibilities

• Provides operational and strategic oversight of the U.S. pharmacovigilance system in compliance with applicable regulations (e.g., FDA, 21 CFR, ICH, EU GVP) and company standards.
• Serves as Deputy LSO, assuming LSO responsibilities as required and representing the affiliate in regulatory and safety matters.
• Leads ongoing safety surveillance, benefit?risk evaluation, signal detection activities, and escalation of safety issues in collaboration with Global PV and QPPV leadership.
• Oversees periodic safety reporting activities (e.g., PSURs, PBRERs, DSURs), ensuring timely, complete, and accurate submissions to health authorities.
• Maintains oversight of Individual Case Safety Report (ICSR) processing, reconciliation activities, and data quality monitoring.
• Provides PV oversight of patient support programs, specialty pharmacy vendors, and other third?party programs, ensuring contractual and regulatory PV obligations are met.
• Leads PV vendor governance, including performance monitoring, compliance with Safety Data Exchange Agreements, and issue remediation.
• Drives inspection readiness strategy for the U.S. affiliate and serves as a subject matter expert during health authority inspections and audits.
• Partners closely with the PV Compliance and Oversight Manager on quality issues, CAPAs, regulatory change implementation, and continuous improvement initiatives.
• Represents PV in cross?functional initiatives, including product launches, regulatory submissions, and safety?related business decisions.
• Provides leadership, mentoring, and performance management for PV team members; supports capability building and workforce planning.
• Identifies gaps, risks, and opportunities within the local PV system and leads initiatives to strengthen compliance, efficiency, and system maturity.

Skills & Qualifications

• Advanced degree (Master's, PharmD, MD, or PhD) in life sciences, pharmacy, medicine, or a related discipline required.
• Professional certifications in pharmacovigilance or drug safety (e.g., ISoP, DIA) preferred.
• 8+ years of progressive experience in pharmacovigilance within the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated experience leading or co?leading local PV operations, including regulatory inspections and health authority interactions.
• Hands?on experience with signal detection, safety surveillance, periodic reporting, and PV vendor oversight.
• Proven people leadership experience, including mentoring and developing PV professionals.
• In?depth knowledge of U.S. and global PV regulations, including FDA requirements, ICH guidelines, EU GVP modules, and GCP.
• Strong scientific judgment with the ability to interpret complex safety data and make benefit?risk assessments.
• Excellent leadership, organizational, and project management skills.
• Strong communication and stakeholder?influencing capabilities across Medical, Regulatory, Quality, and Commercial functions.
• Ability to operate effectively in a matrix organization and manage competing priorities.
• Proficient with PV safety databases, signal detection tools, and quality management systems.
• Fluent in written and spoken English.

About the Compensation:

The base salary range for this role is determined based on several factors. These include but are not limited to job accountabilities; skill sets; experience and training; certifications; work location; competitive market rates and other business needs. At Galderma, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on a unique combination of factors for each role. A reasonable estimate of the hiring range for this role is $160,000- $200,000.

In addition to base salary, we provide an opportunity to participate in an annual short-term incentive program that is based on corporate performance with a multiplier focused on individual performance. We offer a competitive and comprehensive benefits program including health insurance, 401(k) plan with employer match, a generous paid time off policy, hybrid work schedules and more.

What We Offer in Return You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training. Next Steps

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team