Senior Pharmacovigilance Manager

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.

We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.

At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.

Title: Senior Pharmacovigilance Manager

Job Summary

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 LSOs absence.

The role leads daytoday 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 crossfunctional stakeholders to ensure a compliant highperforming 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 benefitrisk 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 thirdparty 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 crossfunctional initiatives including product launches regulatory submissions and safetyrelated 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 (Masters 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 coleading local PV operations including regulatory inspections and health authority interactions.

• Handson experience with signal detection safety surveillance periodic reporting and PV vendor oversight.

• Proven people leadership experience including mentoring and developing PV professionals.

• Indepth 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 benefitrisk assessments.

• Excellent leadership organizational and project management skills.

• Strong communication and stakeholderinfluencing 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 $160000- $200000.

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

Our people make a difference

At Galderma youll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism collaboration and a friendly supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employers Rights

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract and either you or the employer may terminate employment at any time for any addition reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.