Talent.com
Director / Senior Director of Pharmacovigilance

Director / Senior Director of Pharmacovigilance

Vivid ResourcingPrinceton, NJ, US
7 days ago
Job type
  • Full-time
Job description

Director / Senior Director of Pharmacovigilance (On-site)

Location : Princeton, NJ

Employment Type : Full-Time, Executive Leadership

Reports To : Chief Medical Officer

Position Overview

As the Director of Pharmacovigilance will provide strategic leadership and oversight of all global pharmacovigilance and drug safety operations. This executive will ensure the company's compliance with worldwide safety regulations, guide safety risk management strategies across all product life cycles, and foster a high-performance safety culture. Acting as the primary safety authority for the organization whilst partnering with cross-functional stakeholders to safeguard patients while enabling business objectives.

Key Responsibilities

Strategic Leadership & Governance

  • Define and execute the global PV strategy aligned with corporate goals and regulatory expectations.
  • Lead the design and continuous improvement of the PV system, ensuring compliance with FDA, EMA, ICH, and other global health authority requirements.
  • Serve as the company's senior safety spokesperson in regulatory inspections, audits, and external meetings.
  • Chair the Safety Governance Board and oversee all risk–benefit assessments.

Operational Oversight

  • Lead PV teams responsible for case processing, signal detection, aggregate reporting, and risk management.
  • Ensure timely submission of expedited safety reports, periodic safety update reports (PSURs / PBRERs), and development safety update reports (DSURs).
  • Oversee vendor management for outsourced PV activities, ensuring quality and compliance.
  • Implement effective pharmacovigilance quality management systems, including SOPs, training, and CAPA processes.
  • Cross-functional Collaboration

  • Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams to ensure integrated safety strategies.
  • Support labeling decisions, safety-related communications, and benefit–risk assessments for regulatory filings.
  • Engage with KOLs, regulatory agencies, and industry bodies to represent the company's safety position.
  • Team Leadership & Development

  • Build, inspire, and mentor a high-performing PV organization.
  • Foster a culture of operational excellence, scientific rigor, and regulatory compliance.
  • Plan and manage PV budgets and resource allocation.
  • Qualifications & Experience

  • MD, PharmD, or equivalent advanced degree in a medical / scientific discipline.
  • 15+ years in pharmacovigilance or drug safety, with at least 8 years in senior leadership roles.
  • Deep knowledge of global PV regulations (FDA, EMA, ICH E2E, CIOMS).
  • Proven experience managing safety across both clinical development and post-marketing environments.
  • Exceptional leadership skills with the ability to inspire and manage diverse teams.
  • Strong track record of successful regulatory inspections and audits.
  • Bonus skills :

  • Experience in biotech, specialty pharmaceuticals, or immunology / oncology therapeutic areas.
  • Board certification in a relevant specialty.
  • Previous leadership in a mid-to-large size pharma or biotech organization.
  • Compensation & Benefits

  • Competitive executive-level base salary and performance bonus.
  • Long-term equity incentives.
  • Comprehensive health, dental, and retirement benefits.
  • Relocation assistance (if applicable).
  • Create a job alert for this search

    Of Pharmacovigilance • Princeton, NJ, US

    Related jobs
    • Promoted
    Director, Reimbursement Insights & Analytics - NS

    Director, Reimbursement Insights & Analytics - NS

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    The Insights and Decision Science (IDS) team is dedicated to enabling improved decision making at Novartis by leveraging data and advanced analytics capabilities to generate actionable insights tha...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Program Director

    Program Director

    Beacon Specialized LivingNew Jersey, US
    Full-time
    Position Summary : • The Program Director oversees assigned Beacon locations to ensure that company goals, budgets, and clinical effectiveness targets are met. They support Care Team Managers by ensur...Show moreLast updated: 15 hours ago
    • Promoted
    Senior Director, Global Medical Affairs, Oncology (Neuro-Oncology)

    Senior Director, Global Medical Affairs, Oncology (Neuro-Oncology)

    Jazz PharmaceuticalsPhiladelphia, PA, United States
    Full-time
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...Show moreLast updated: 6 days ago
    • Promoted
    Director, Pharmacy Strategy & Operations

    Director, Pharmacy Strategy & Operations

    New Jersey StaffingTrenton, NJ, US
    Full-time
    Director, Pharmacy Strategy & Operations.At Navista, our mission is to empower community oncology practices to deliver patient-centered cancer care. Navista, a Cardinal Health company, is an oncolog...Show moreLast updated: 6 days ago
    • Promoted
    RN Case Manager - Utilization Review

    RN Case Manager - Utilization Review

    Deborah Heart and Lung CenterBrowns Mills, NJ, US
    Full-time
    The Utilization Review Case Manager validates the patient�s placement to be at the most appropriate level of care based on nationally accepted admission criteria. The UR Case Manager uses med...Show moreLast updated: 30+ days ago
    • Promoted
    161425 - Administrative Lab Director

    161425 - Administrative Lab Director

    A-Line Staffing Solutions LLCToms River, NJ, US
    Full-time +1
    Full-time, Fully Onsite (Not Remote).The Director will be responsible for ensuring the delivery of high-quality, compliant, and efficient laboratory services across multiple sections, including Cor...Show moreLast updated: 5 days ago
    • Promoted
    Director, PSC (Patient Support Center) Operations Insights

    Director, PSC (Patient Support Center) Operations Insights

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    The Insights and Decision Science (IDS) team is dedicated to enabling improved decision making at Novartis by leveraging data and advanced analytics capabilities to generate actionable insights tha...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Audit & Oversight

    Senior Director, Audit & Oversight

    WelbeHealthTrenton, NJ, United States
    Permanent
    WelbeHealth is a value-based healthcare organization that's transforming the future of senior care by providing an all-inclusive care option to our most vulnerable senior population.Under the direc...Show moreLast updated: 8 days ago
    Associate Director / Director of Drug Safety

    Associate Director / Director of Drug Safety

    SystimmunePrinceton, NJ, US
    Full-time
    Quick Apply
    SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its establi...Show moreLast updated: 30+ days ago
    • Promoted
    Global LCM Senior Medical Director

    Global LCM Senior Medical Director

    SanofiMORRISTOWN, NJ, US
    Full-time
    Global LCM Senior Medical Director.This role is part of Global Medical Affairs team for Neurology within Specialty Care Medical Affairs. Our Medical Affairs function serves as key strategic partners...Show moreLast updated: 2 days ago
    • Promoted
    Psychiatry

    Psychiatry

    CompHealthFlemington, New Jersey, US
    Full-time +1
    Psychiatry physician job in New Jersey : You will enjoy working in this great little New Jersey town.It has convenient shopping, access to the countryside, great schools, and a quaint, historic dow...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Executive Director, Outcomes Research (HIV / ID)

    Executive Director, Outcomes Research (HIV / ID)

    MerckRahway, NJ, US
    Full-time
    Executive Director, Value & Implementation (V&I) Outcomes Research.The Executive Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes G...Show moreLast updated: 2 hours ago
    • Promoted
    State Director

    State Director

    Best Buddies InternationalClinton, New Jersey, US
    Full-time
    Best Buddies International is a nonprofit 501(c)(3) organization dedicated to establishing a global volunteer movement that creates opportunities for one-to-one friendships, integrated employment, ...Show moreLast updated: 30+ days ago
    Director / Senior Director, Clinical Development

    Director / Senior Director, Clinical Development

    SystimmunePrinceton, NJ, US
    Full-time
    Quick Apply
    SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its establi...Show moreLast updated: 30+ days ago
    • Promoted
    Occupational Medicine

    Occupational Medicine

    KPG Provider ServicesLanghorne, Pennsylvania, US
    Full-time +1
    Occupational Medicine physician job in Pennsylvania : Inpatient Facility : Looking for an experienced Medical Director Occupational Medicine in the Langhorne, Pennsylvania area.Below you will find...Show moreLast updated: 30+ days ago
    • Promoted
    Data Science Associate Director

    Data Science Associate Director

    BioPharm Communications LLCNew Hope, PA, US
    Temporary
    Data Science Associate Director (BioPharm Communications LLC, New Hope, PA) Conduct research, build prototypes and drive production of new analytical product offerings. Execute ad-hoc analysis in a ...Show moreLast updated: 15 days ago
    • Promoted
    APN - Hospital Medicine

    APN - Hospital Medicine

    Deborah Heart and Lung CenterBROWNS MILLS, NJ, US
    Full-time
    Position Summary : Participation in the clinical activities of Deborah Heart and Lung Center Hospital Inpatient Service.Responsible daily evaluation and management (under physician supervision) bil...Show moreLast updated: 5 days ago
    • Promoted
    Director / Senior Director, Commercial Operations

    Director / Senior Director, Commercial Operations

    Aquestive TherapeuticsWarren, NJ, US
    Full-time
    The Senior Director, Commercial Operations plays a pivotal role in shaping and executing Aquestive Therapeutics’ commercial launch strategy and reports to the Chief Commercial Officer as a strategi...Show moreLast updated: 19 days ago