Senior Pharmacovigilance Manager

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 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. Compensation & Benefits The base salary range for this role is $160,000–$200,000, determined based on factors such as job accountabilities, skill sets, experience, training, certifications, work location, and market rates. In addition to base salary, this role is eligible for an annual short‑term incentive program linked to corporate performance, as well as comprehensive benefits including health insurance, a 401(k) plan with employer match, paid time off, and hybrid work schedules. Employer’s 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 reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. #J-18808-Ljbffr Dormont Manufacturing Co