Senior Pharmacovigilance Manager

🕒 April 28

🏢🏡 Boston – Hybrid

💵 $160k - $200k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Galderma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1981

💄 Beauty

🧬 Biotechnology

💊 Pharmaceuticals

Beauty • Biotechnology • Pharmaceuticals

Galderma is a global company that focuses on dermatology, offering a diverse range of products and services across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. With a strong emphasis on innovation, Galderma develops and delivers cutting-edge, premium brands tailored to individual skin needs. The company's mission is to advance dermatology for every skin story, acknowledging the unique nature of every individual's skin. Galderma operates with a global presence and engages in partnerships to bring its dermatological innovations to life while also being committed to sustainability and governance oversight.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Health insurance • 401(k) plan with employer match • Generous paid time off policy • Hybrid work schedules • Annual short-term incentive program