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Pharmacovigilance Specialist, PV QMS

3 weeks ago

Bridgewater Twp, NJ, United States Bausch Health Full time

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

The PV QMS & Training Specialist is responsible for supporting the implementation, maintenance, and continuous improvement of the Pharmacovigilance Quality Management System (PV QMS). This role ensures that pharmacovigilance staff and partners are trained appropriately and that QMS documentation is maintained to support inspection readiness and continuous improvement. This role also leads the development and delivery of training programs to ensure compliance with global pharmacovigilance regulations and internal standards.

Key Responsibilities:

  • Quality Management System (QMS):

  • Maintain and update controlled procedural documents (SOPs, work instructions).

  • Support deviation and CAPA tracking, documentation, and follow-up.

  • Assist in audit preparation and inspection readiness activities.

  • Monitor QMS performance metrics and support reporting.

  • Training Coordination:

  • Coordinate the development, scheduling, and delivery of PV-related training programs.

  • Maintain training records and ensure compliance with regulatory and internal training requirements.

  • Support onboarding and offboarding processes for PV staff and vendors.

  • Facilitate communication of training events and updates across teams.

  • Documentation & Compliance:

  • Manage electronic document repositories and training management systems.

  • Ensure accurate and timely documentation of training activities and QMS updates.

  • Support reconciliation of safety data logs and regulatory submissions.

  • Assist in the development of tools and templates to improve PV compliance and productivity.

  • Collaboration & Support:

  • Liaise with internal stakeholders and external partners to ensure alignment on training and QMS processes.

  • Support external audits and inspections by regulatory authorities.

  • Provide logistical support for meetings, audits, and regulatory responses.

  • Participate in cross-functional initiatives to enhance PV quality and compliance.

Qualifications:

  • Bachelors degree in Life Sciences, Analytics, Informatics or related field.

  • 13 years of experience in pharmacovigilance, quality assurance, or training coordination.

  • Familiarity with global PV regulations (e.g., FDA, EMA, ICH, GVP).

  • Experience with QMS and LMS platforms (e.g., Veeva, ETQ, ComplianceWire).

  • Strong organizational, communication, and interpersonal skills.

  • Detail-oriented with the ability to manage multiple priorities.

The range of starting base pay for this role iis 61K - 84K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.

#LI-hybrid

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.