Full-Time

Patient Safety Lead

Pharmacovigilance

Posted on 9/28/2025

Deadline 10/13/25
Roche

Roche

1-10 employees

Global pharmaceuticals and diagnostics company

No salary listed

Mississauga, ON, Canada

In Person

Relocation Benefits are available for this job posting.

Category
Medical, Clinical & Veterinary (1)
Required Skills
Risk Management
Requirements
  • An experienced people leader with 10+ years of experience in pharmacovigilance (PV) within an affiliate setting, and knowledge of global/local PV ecosystems.
  • Degree in Medicine or Healthcare Practitioner required.
  • Proven ability to design, implement, and maintain streamlined PV processes and oversight systems that ensure compliance and effectiveness.
  • Strategic mindset with strong critical thinking, systems thinking, and outcome-based planning skills.
  • Ability to effectively navigate cross-functional collaboration, influence stakeholders, and develop internal and external partnerships within the pharma and healthcare ecosystem.
Responsibilities
  • Maintain comprehensive oversight of the local pharmacovigilance (PV) system, ensuring compliance with global and local regulatory requirements, inspection readiness, and acting as the single point of contact for safety-related aspects, including as Qualified Person for Pharmacovigilance (QPPV), where required.
  • Partner with Pharmacovigilance Hubs in the efficient execution of PV operations, including case safety management, signal detection, risk management, safety reporting, and implementation of PV agreements, enabling the effective monitoring of product safety and regulatory compliance.
  • Drive the local Patient Safety strategy in collaboration with cross-functional teams, aligning with affiliate business priorities and customer-centric objectives to deliver impactful safety outcomes and ensure readiness for launches, precision medicine, and other strategic activities.
  • Proactively shape the local regulatory and healthcare environment by partnering with external stakeholders such as industry associations, healthcare organizations, and patient groups to enhance patient safety and robust healthcare systems.
  • Support affiliate and global functions as a trusted safety expert, delivering actionable safety insights and co-creating impactful solutions for safe treatment delivery, patient and healthcare provider needs, regulatory submissions, and long-term safety risk management.
  • Collaborate actively with the Safety Network (NET) to exchange expertise and resources, drive high-priority global and local initiatives, and ensure the affiliate Patient Safety team contributes meaningfully to advancing global safety goals.
  • Empower and upskill the local Patient Safety team or partners, fostering self-management, operational PV excellence, and local application of safety science to address unmet patient safety needs, enhance treatment outcomes, and improve the patient experience.
Desired Qualifications
  • Experience in medical functions such as Medical Affairs or Clinical Operations, or in global roles like product development or clinical safety.
  • Strong understanding of new therapeutic areas, digital health, and data-driven insights to advance safety initiatives.
  • Visionary leadership capabilities, including coaching, catalyzing cultural shifts in PV, and inspiring safety-focused strategies.
  • Digital fluency, including using digital tools and leveraging network expertise to fulfill local PV and patient safety needs.
  • Ability to simplify and adapt complex safety knowledge for local contexts while promoting a customer- and patient-centric mindset.

Roche is a global leader in pharmaceuticals and diagnostics. It develops medicines and diagnostic tools that help detect, monitor, and treat diseases, using research and biotechnology to drive new therapies and tests. Roche combines drug development with in-house diagnostic products to support personalized medicine, where treatments are tailored to individual patients based on test results. Its approach differs from many peers by integrating drug discovery with diagnostic capabilities and by expanding its research through strategic acquisitions (like Genentech) to strengthen its biotechnology and R&D capabilities. The company’s goal is to improve patient outcomes and healthcare worldwide by delivering reliable medicines, accurate diagnostic tests, and data-driven care.

Company Size

1-10

Company Stage

IPO

Headquarters

Basel, Switzerland

Founded

1896

Simplify Jobs

Simplify's Take

What believers are saying

  • CT-388 targets double-digit share in obesity market alongside Novo Nordisk and Lilly.
  • PathAI $750M acquisition scales AI digital pathology globally by late 2026.
  • Elecsys pTau217 Alzheimer's blood test launches in CE markets from July 2026.

What critics are saying

  • Rituxan patent expiry lets Sandoz biosimilars slash 40% lymphoma share in 6-12 months.
  • Swiss franc 12% rise compresses US 55% revenues as hedges expire in 6-18 months.
  • US IRA forces 60-80% discounts on Herceptin, Avastin from 2028, cutting $4B cashflow.

What makes Roche unique

  • Roche integrates pharmaceuticals and diagnostics via 1991 PCR acquisition from Cetus.
  • 1990 Genentech majority stake pioneered oncology antibodies like Herceptin and Rituxan.
  • Personalized healthcare strategy couples diagnostics to targeted therapies since 2009 full acquisition.

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