Principal Director of Pharmacovigilance Solutions

4 weeks ago

New Brunswick, New Jersey, United States YD Talent Solutions Full time
About Our Client

Our client is a pioneering provider of cutting-edge Pharmacovigilance Technology Solutions. They bring unparalleled expertise in drug safety, paired with innovative technology, including AI and GenAI. Their forward-thinking solutions tackle the most pressing challenges in the pharmaceutical industry, driving both operational efficiency and enhanced business performance.

Their offerings include proprietary products for automated case intake, advanced reporting platforms, GenAI-based solutions, and expert services such as Business Transformation, Safety Systems Consulting, Data Migration, and Computer System Validation. These flexible and scalable solutions are designed to meet the needs of both large global companies and smaller organizations across diverse markets. With a focus on improving data accuracy, optimizing workflows, and ensuring patient safety, their solutions enable clients to address regulatory requirements while reducing operational costs. By streamlining complex safety processes, they empower pharmaceutical companies to drive lasting business value and maintain a competitive edge in a rapidly evolving industry.

Position Overview

· Position: Principal / Associate Director / Solution Lead – Pharmacovigilance (PV) SME
· Location: East Coast, USA
· Experience: 15+ years

Requirements

Key Roles and Responsibilities:

  • Expertise in PV Business Processes and Safety Systems Configuration: Combine deep knowledge of Pharmacovigilance business processes with hands-on expertise in configuring PV systems (e.g., Oracle Argus Safety) to ensure that systems are aligned with both operational needs and regulatory requirements. Drive system configurations to optimize performance, data accuracy, and compliance.
  • Requirements Gathering & Analysis: Collaborate with stakeholders to gather and analyze system requirements, ensuring tailored configurations that meet both business and regulatory demands.
  • Knowledge of Global PV Regulations: Ensure compliance with regulations from major health authorities (e.g., MHRA, EMA, FDA, TGA, Health Canada, PMDA) through proper system configuration and governance.
  • Governance & Oversight: Provide strategic guidance on safety system updates, driving alignment with evolving business goals and regulatory standards. Lead cross-functional teams in implementing system changes and ensuring ongoing compliance.
  • Workflow Optimization: Continuously assess and improve system workflows to enhance efficiency and streamline operations in line with PV best practices.
  • Regulatory Reporting: Oversee the development of key reports, such as Aggregate Reports, Signal Detection, and KPIs, ensuring compliance with global PV regulations.
  • Technology Understanding: Possess a strong understanding of the technologies involved in Pharmacovigilance systems, particularly in relation to system configurations, data handling, and integration with other enterprise platforms. While not an expert-level requirement, the candidate should understand how these systems fit within the broader technology ecosystem of a PV organization.
  • Data Migration: Have a foundational understanding of data migration processes related to safety systems, ensuring seamless transitions between systems and accurate data transfers. Provide insights into how data migration impacts the system configurations and business processes.
  • BI Reporting & Analytics: Have a working knowledge of Business Intelligence (BI) reporting and analytics, ensuring that system configurations support effective reporting, including compliance and safety performance dashboards. Understand how BI tools are integrated with safety systems for real-time monitoring and reporting.

Behavioral Skills:

  • Stakeholder Engagement: Engage effectively with cross-functional teams, regulatory bodies, and external stakeholders to ensure alignment on system requirements. Leverage strong communication and negotiation skills to manage stakeholder expectations and align configurations with business goals.

  • Adaptability: Quickly respond to changes in regulatory standards and business needs in a fast-paced environment. Demonstrate flexibility in adjusting to new challenges and evolving demands in the PV landscape.

  • Leadership: Provide leadership in cross-functional projects, mentor junior team members, and support strategic decision-making. Guide teams through system implementations and improvements, ensuring alignment with business objectives.

  • Critical Thinking: Apply strong analytical skills to solve complex configuration challenges while ensuring regulatory and business objectives are met. Proactively identify potential issues and develop solutions that maintain system integrity and compliance.


Ideal Candidate Profile:

The ideal candidate will be an expert in Pharmacovigilance business processes and Safety Systems configuration, with extensive experience in global PV regulations and requirements analysis. They should also have a strong understanding of technology, data migration, and BI reporting as they relate to PV systems, with the ability to oversee end-to-end processes and ensure compliance. This role offers opportunities for growth into senior leadership positions as the company expands globally.

Why Join Our Client:

Join a dynamic, people-centric environment that values ownership and accountability. We offer a nurturing culture that provides opportunities for growth and development, recognizing your contributions based on merit. You will be part of a team with decades of experience in life sciences, working on impactful projects that shape the future of industry. Collaborate with innovative technologies, drive change, and grow your career with us. Enjoy professional development, leadership opportunities, and the chance to make a real difference in a fast-evolving field.


  • Pharmacovigilance Specialist

    3 weeks ago

    New Brunswick, New Jersey, United States Actalent Full time

    Job Title:PHARMACOVIGILANCE SPECIALISTThe Pharmacovigilance PV Analytics and Reporting Specialist PV Analytics Center of Excellence is responsible for the successful execution and close-out of activities aligned with the overall vision, strategy, and objectives of the Global Biostatistics Data Sciences Function.This role contributes to the ongoing...

  • Pharmacovigilance Analytics Specialist

    4 weeks ago

    New Brunswick, New Jersey, United States Actalent Full time

    Job Title:PHARMACOVIGILANCE ANALYTICS SPECIALISTJob DescriptionThe Pharmacovigilance PV Analytics and Reporting Specialist is responsible for the successful execution and close-out of activities aligned with the overall vision, strategy, and objectives of the Global Biostatistics Data Sciences Function. This role contributes to the ongoing development,...

  • Senior Director, Head of Pharmacovigilance

    4 weeks ago

    New York, New York, United States Planet Pharma Full time

    Job Title: Senior Director, Head of PharmacovigilanceAt Planet Pharma, we are seeking a highly experienced Senior Director to lead our Pharmacovigilance function. As a key member of our leadership team, you will be responsible for developing and executing our global pharmacovigilance strategy, ensuring the safety of our assets throughout their...

  • Pharmacovigilance Analytics Specialist

    4 weeks ago

    New Brunswick, New Jersey, United States Ivory Systems Full time

    Job Title: Pharmacovigilance Analytics SpecialistAt Ivory Systems, we are seeking a highly skilled Pharmacovigilance Analytics Specialist to join our team. This role is responsible for the successful execution and close-out of activities aligned with the overall vision, strategy, and objectives of the Global Biostatistics & Data Sciences Function.Key...

  • Senior Pharmacovigilance Lead

    4 weeks ago

    New Providence, New Jersey, United States ADC Therapeutics America, Inc. Full time

    Job Summary:We are seeking a highly skilled Director, Pharmacovigilance Scientist to join our team at ADC Therapeutics America, Inc. in the Global Drug Safety function. In this critical role, you will collaborate with the Global Safety Physician (GSP), other functions, and vendors to ensure the safe and effective development of our products.Key...

  • Director of Pharmacovigilance and Drug Safety Operations

    4 weeks ago

    New York, New York, United States ROIVANT SCIENCES LTD Full time

    Job Summary:The Director of Pharmacovigilance and Drug Safety Operations will provide strategic and tactical oversight for Roivant's drug safety operations, handling program-level drug safety/PV activities. This role will work closely with the existing drug safety team and the head of regulatory affairs and drug safety to ensure all aspects of drug safety...

  • Director, Pharmacovigilance Quality Oversight AI Lead

    3 weeks ago

    New York, New York, United States Pfizer Full time

    Pharmacovigilance AI Quality Oversight LeadROLE SUMMARYThe Pharmacovigilance AI Quality Oversight Lead is responsible for overseeing the strategic development and implementation of quality plans, establishing guidelines, and managing oversight governance to ensure the quality and reliability of AI systems that may affect pharmacovigilance.This involves...

  • Senior Medical Director-Global Drug Safety Expert

    3 weeks ago

    New Providence, New Jersey, United States ADC Therapeutics SA Full time

    Job Title: Senior Medical Director-Global Drug Safety ExpertADC Therapeutics SA is seeking a highly skilled Senior Medical Director-Global Drug Safety Expert to join our team. As a key member of our Global Drug Safety function, you will be responsible for ensuring the safety of our products throughout their lifecycle.Key Responsibilities:Lead safety signal...

  • International Tax Director/Principal

    4 weeks ago

    New York, New York, United States Tandym Group Full time

    A leading public accounting firm in New York City seeks an experienced International Tax professional to join their staff as their new International Tax Director / Principal.Key Responsibilities:The International Tax Director / Principal will:Drive multiple on-going projects through effective collaboration with professional staffDevelop and maintain strong...

  • International Tax Director/Principal

    4 weeks ago

    New York, New York, United States Tandym Group Full time

    International Tax Director/Principal OpportunityA leading public accounting firm in New York City is seeking an experienced International Tax professional to join their staff as their new International Tax Director/Principal.Key Responsibilities:Oversee and drive multiple on-going projects through effective collaboration with professional staff.Develop and...

  • Associate Director, Principal Giving

    4 weeks ago

    New York, New York, United States International Rescue Committee Full time

    Job Title:Associate Director, Principal GivingJob Summary:The International Rescue Committee (IRC) is seeking a seasoned fundraiser and relationship cultivator to serve as the Associate Director of Principal Giving in the Eastern United States. This role will work closely with the Senior Director of USA Philanthropy East and the Director of Principal Giving...

  • Principal Field Solution Architect

    4 weeks ago

    New York, New York, United States CDW Full time

    Job Title: Principal Field Solution ArchitectJob Summary:CDW is seeking a highly skilled Principal Field Solution Architect to join our team. As a key member of our sales team, you will be responsible for designing and implementing technical solutions for our customers. You will work closely with our sales team to develop and execute sales strategies, and...

  • Rutgers University Senior Research Director

    3 weeks ago

    New Brunswick, New Jersey, United States Rutgers University Full time

    Job SummaryRutgers University is seeking a highly skilled and experienced professional to fill the position of Managing Director within the Rutgers Cancer Institute of New Jersey. The successful candidate will be responsible for leading the Biorepository and Histopathology Service (BRHS) Shared Resource, which provides critical support to cancer researchers...

  • Director, Principals Program Lead

    3 weeks ago

    New York, New York, United States Facing History and Ourselves, Inc Full time

    Job OverviewFacing History and Ourselves, Inc is seeking an experienced and dynamic Director, Principals Program to join the Growth and School Engagement team.The ideal candidate will have a strong background in education, with a minimum of 5-7 years of experience in educational settings, preferably in NYC. They will be responsible for cultivating close...

  • Director of Solution Engineering

    4 weeks ago

    New York, New York, United States City of New York Full time

    About the Role:The City of New York is seeking a highly skilled Director of Solution Engineering to join its Information Technology Services team. As a key member of the Enterprise Solutions Engineering office, you will be responsible for establishing control and process over the software development life-cycle, delivery of shared APIs, and user experience...

  • Chief Medical Service Director

    3 weeks ago

    New Brunswick, New Jersey, United States DaVita Full time

    Job Summary:The Managing Director, Biorepository and Histopathology Service (BRHS) Shared Resource (SR) is responsible for developing and promoting the use of services relevant to its mission, which is to consent, bank, and distribute biospecimens, and offer standard and complex tissue analysis, and tumor microarrays.The BRHS SR is used by more than 60...

  • Principal Product Manager

    3 weeks ago

    New York, New York, United States Intuit Inc Full time

    About the RoleWe're seeking a highly skilled Principal Product Manager to lead the development of innovative ecommerce solutions at Intuit Inc. As a key member of our team, you'll be responsible for shaping the future of ecommerce marketing and customer engagement.With a strong background in product management and a passion for ecommerce, you'll drive the...

  • Director of Biorepository and Histopathology Service

    4 weeks ago

    New Brunswick, New Jersey, United States Rutgers The State University Full time

    Rutgers The State University is seeking a highly skilled and experienced professional to fill the role of Managing Director within the Rutgers Cancer Institute of New Jersey.The primary purpose of this position is to develop and promote the use of services relevant to the mission of the Biorepository and Histopathology Service (BRHS) Shared Resource (SR)....

  • Quantitative Solutions Director

    4 weeks ago

    New York, New York, United States Bank of America Full time

    Job DescriptionThe Quantitative Solutions Director will lead the development of data-driven solutions to drive business growth and improve client experience. This role will collaborate with cross-functional teams to identify opportunities for automation, data analysis, and process improvement.Key ResponsibilitiesDevelop and implement data-driven solutions to...

  • Associate Director, Principal Giving

    4 weeks ago

    New York, New York, United States International Rescue Committee Full time

    Job Title: Associate Director, Principal GivingThe International Rescue Committee (IRC) is seeking a seasoned fundraiser and relationship cultivator to serve as the Associate Director of Principal Giving in the Eastern United States.Job Overview:The External Relations (ER) department is comprised of three main functional areas: Private fundraising,...