Central Operations Specialist (PV, Pharmacovigilance)

Posted 7 Days Ago
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Budapest, HUN
In-Office
Junior
Healthtech • Biotech • Pharmaceutical
The Role
Oversee global pharmacovigilance and medical device safety reporting operations, including ICSR processing, data quality, compliance, vendor coordination, inspection readiness, metrics, and regulatory reporting. Support AI-enabled safety activities, continuous process improvement, governance, issue escalation, and cross-functional projects while ensuring adherence to global pharmacovigilance requirements.
Summary Generated by Built In

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity

Are you ready to play a pivotal role in transforming how patient safety data is delivered globally?

As our Central Operations Specialist within Patient Safety Operations, you will be at the heart of our mission to ensure the efficient, high-quality, and compliant delivery of safety data outputs. You will process and report Individual Case Safety Reports (ICSRs) and device safety reports, via the utilisation of current/future safety systems, and use of vendor services, and co-develop innovative approaches for the transformation and reporting of wider types of safety-relevant data, beyond ICSRs.

In this dynamic role, you will collaborate closely with global vendors, business process owners, and cross-functional teams to maintain our inspection readiness and drive continuous improvements. You will have the unique opportunity to support change initiatives, explore cutting-edge technologies like artificial intelligence in pharmacovigilance, and guide our operations to meet both current and future regulatory requirements.

  • Oversee Safety Data Quality: Monitor workload, compliance, and quality across the global ICSR footprint to ensure internal and external performance standards are consistently met.

  • Manage Vendor & Process Collaboration: Support the oversight, coordination, and inspection readiness of ICSR and medical device safety activities in collaboration with external vendors and internal alliance managers.

  • Drive Continuous Improvement: Develop, maintain, and review metrics and KPIs to identify and execute process enhancements within safety reporting sub-processes.

  • Lead AI & Innovation Initiatives: Support the implementation of AI-augmented activities and human-in-the-loop interventions to optimize operational safety report delivery.

  • Provide Governance & Subject Matter Expertise: Act as a key point of contact for queries and issue escalations, supporting Case Processing Governance across Patient Safety Operations sites.

  • Support Regulatory Reporting Projects: Execute and coordinate regulatory reporting projects for Roche products by preparing documentation and ensuring adherence to established quality standards.

Who You Are

  • Industry Experience: A minimum of 2 years of relevant experience within the pharmaceutical industry, preferably with an emphasis on pharmacovigilance.

  • PV Knowledge: Strong working knowledge of global Pharmacovigilance regulatory obligations and compliance standards.

  • Project & Conflict Management: Proven ability to support or lead projects to a successful conclusion while demonstrating strong problem-solving and conflict-resolution skills.

  • Agile Mindset: Comfort working in a matrix environment, actively participating in or leading agile squads and sprints to deliver on business strategies.

  • Educational Background: A minimum of a degree-level qualification in a scientific or relevant field.

This position is based in Budapest, Hungary. Relocation Assistance is not available.

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Skills Required

  • Minimum 2 years of relevant experience within the pharmaceutical industry, preferably in pharmacovigilance
  • Strong working knowledge of global pharmacovigilance regulatory obligations and compliance standards
  • Proven ability to support or lead projects to successful completion
  • Strong problem-solving and conflict-resolution skills
  • Comfort working in a matrix environment and participating in or leading agile squads and sprints
  • Degree-level qualification in a scientific or relevant field

Roche Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.

  • Retirement Support U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
  • Leave & Time Off Breadth Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
  • Healthcare Strength Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.

Roche Insights

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The Company
Provincia de Buenos Aires
93,797 Employees
Year Founded: 1896

What We Do

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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