Roche

Patient Safety Lead- Pharmacovigilance

Roche  •  Buenos Aires, AR (Onsite)  •  23 hours ago
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Job Description

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

As a Patient Safety Lead, you will be responsible for inspiring and driving the local Patient Safety strategy while ensuring the implementation, maintenance, and compliance of an effective local Pharmacovigilance (PV) system. In this role, you will act as the primary single point of contact (or QPPV where locally required) for internal and external stakeholders, providing strategic leadership under the VACC model (Visionary, Architect, Coach, Catalyst) to transform local PV from a reporting function into an impactful, patient-centric strategic driver.

The Opportunity

  • Maintain holistic oversight of local PV compliance, inspection readiness, and serve as the single point of contact or QPPV for Health Authorities and internal networks.

  • Oversee the operational execution of key safety activities, including ICSRs, signal management, aggregate reports, PVAs, risk minimization measures (aRMM), and safety labeling.

  • Drive the local Patient Safety strategy integrated with therapeutic area goals, partnering with cross-functional teams (Medical, Access, PJPs/HSPs) to address unmet safety needs.

  • Shape the local regulatory safety environment by engaging with external stakeholders, industry associations, and healthcare organizations to build safer, robust systems.

  • Provide expert thought partnership on strategic affiliate projects, such as product launches, RWE data generation, safe home treatment, and HTA discussions.

  • Empower and coach self-organizing local Patient Safety Partners, fostering a continuous learning culture and ensuring proper resource allocation.

  • Connect local priorities with the global Safety NET and regional hubs to pull in expertise, share co-created solutions, and scale high-impact patient safety initiatives.

Who you are

  • University degree in Medicine (MD), Pharmacy, Healthcare, or PhD/Master’s in Life Sciences/Public Health meeting local QPPV qualification standards.

  • Significant experience (3-5+ years) in Pharmacovigilance within an affiliate setting, with additional experience in Medical Affairs or Clinical Development considered advantageous.

  • Deep technical expertise in local and global PV regulations, system oversight, risk management, and the ability to navigate complex healthcare ecosystems.

  • Strong strategic mindset, customer-centricity, and proven cross-functional leadership under the VACC model (Visionary, Architect, Coach, Catalyst).

  • Advanced and fluent English & Spanish language skills combined with a digital-first approach to leverage regional resources and contribute to global safety networks.

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.

Roche

About Roche

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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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Switzerland 🇨🇭 , CH
Year Founded
Unknown
Website
roche.com
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