(Senior) Director Pharmacovigilance Operations

3 hours, 28 minutes ago
Full-time
Executive
Project and Program Management
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001

Description

  • Execute the Central PV Services strategy in alignment with business-unit objectives.
  • Oversee ICSR processing, literature surveillance, signal and benefit-risk management, aggregate reporting, and operational excellence activities.
  • Build, expand, and optimize global PV delivery hubs and centralized operating models.
  • Develop outsourcing, workforce, capacity-planning, and resource strategies to support scalable delivery.
  • Drive process standardization, automation, AI adoption, digital transformation, and continuous improvement.
  • Ensure compliance with regulations, contractual obligations, quality standards, and client expectations; support inspections, audits, and CAPAs.
  • Monitor operational and quality KPIs, escalate risks, and report performance to senior management.
  • Support financial planning, pricing, proposals, bids, cost optimization, and growth across existing and new clients.
  • Lead and develop the Central PV Services leadership team, including succession planning and organizational capability building.
  • Collaborate with QPPV, safety, technology, medical information, quality, regulatory, commercial, legal, and business development functions.

Requirements

  • MD, PharmD, PhD, MSc, or equivalent scientific degree preferred.
  • At least 12 years of pharmacovigilance experience.
  • At least 5 years of progressive leadership experience managing global PV operations.
  • Demonstrated experience leading centralized PV services and global delivery organizations.
  • Extensive knowledge of case processing, literature surveillance, signal detection, benefit-risk management, and aggregate reporting.
  • Experience building global shared-service centers and scalable outsourcing models.
  • Strong knowledge of EU GVP Modules, ICH guidelines, FDA requirements, and global PV regulations.
  • Experience supporting regulatory inspections and client audits.
  • Strong understanding of safety databases and PV technologies, including emerging automation and AI capabilities.
  • Professional-level English communication skills, with strong leadership, stakeholder influence, negotiation, commercial, decision-making, coaching, and change-management abilities.

Benefits

  • Remote work, workation options, and flexible arrangements.
  • Performance-based annual bonus.
  • Additional health insurance plus personal accident and business-trip coverage.
  • Wellness and health initiatives.
  • Professional growth and development in the life sciences industry.
  • International team environment with team-building events, global meetings, and B Active activities.

Interested in this position?

Apply directly on the company website

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