Manager Medical Safety

Philip Morris International; Neuenburg; Vor Ort; CHF 130.000 - 190.000; Vollzeit

Zusammenfassung

PMI is seeking a Manager Medical Safety in Neuchatel to provide robust safety expertise across the product lifecycle. You will oversee adverse event reporting, safety surveillance, and risk management for assigned products.

The role requires a Medical Doctor with strong pharmacovigilance knowledge and ability to work within cross-functional teams to ensure GVP/GCP compliance and regulatory readiness.

Qualifikationen

• Medical Doctor degree required.
• Experience in medical safety and adverse event reporting.
• Knowledge of ICH GCP and GVP standards.
• Familiarity with pharmacovigilance regulatory requirements.

Aufgaben

• Review and assess adverse events and serious adverse events per regulatory requirements.
• Support and review study protocols and safety reports (e.g., SURs).
• Oversee signal detection and safety trending; drive risk mitigation.
• Deliver safety training to internal and external stakeholders.

Kenntnisse

Medical safety

Safety signal detection

Adverse event reporting

ICH GCP

GVP

Regulatory compliance

Pharmacovigilance automation & AI

Data visualization

Ausbildung

Medical Doctor

Tools

Pharmacovigilance systems

Safety reporting tools

Jobbeschreibung

At PMI, we’ve chosen to do something incredible. We’ve transformed our business and are building our future on one clear purpose—to deliver a smoke-free future.
With huge change comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.
We're looking for a Manager Medical Safety located in Neuchatel to provide robust safety expertise for assigned products through lifecycle management.

Impact You'll Own

• Be responsible for the product safety surveillance program
• Oversee adverse events collection, evaluation, processing, assessment, reporting during and after clinical studies and post marketing safety surveillance.

What You’ll Do

• Ensure review/medical assessment of reported adverse events and serious adverse events. Apply standard pharmacovigilance procedures and guarantee compliance with requirements for adverse events’ assessment and regulatory reporting.
• Support and review study protocol writing including all clinical study related documents; review of Safety Update Reports (SURs). Provide clinical information and safety reports as required by regulatory agencies/ethics committees (from clinical studies and consumer usage, spontaneous or solicited sources)
• Oversee and assess safety trending/signal detection processes. Drive decision making on identified product risks. Participates in the resolution of legal liability, in compliance with internal standards/procedures as well as regulations - e.g. Good pharmacovigilance practices (GVP) and Good clinical practices (GCP)
• Keep abreast of applicable rules/regulations. Create/deliver safety training to internal and external parties, within clinical evaluation projects.

Skills & Experience

• Medical Doctor
• Demonstrated experience in medical safety, safety signal detection and adverse event reporting
• Good knowledge of ICH CGP, GVP, Regulatory Compliance, Pharmacovigilance and related standards
• Strong proactive communication, flexibility/adaptability, within multi-functional teams.
• Influence, Data Visualization, Data-Driven Storytelling, Category & Portfolio Knowledge, Pharmacovigilance Automation & AI Tools, Periodic Safety Update Reporting, Safety Data Systems.

What We Offer

Our success depends on the talented people who come to work every single day with a sense of purpose and an appetite for progress.

You will join a company that invests in you. We will support your growth as an employee through individual development and structured career management. You will join a dynamic, fast-paced work environment in a constantly evolving industry. Our employees have the courage, curiosity, and conviction to see possibilities where others only see challenges. We offer a competitive salary and benefits package.

Application Process

• Application review
• Initial conversation with Talent Acquisition
• Interview with Hiring Manager and Peers

Equal Opportunities Statement

We believe that diverse perspectives and experiences make us stronger. As an equal opportunity employer, we are committed to creating a workplace where every individual feels welcomed, respected, valued, and empowered to reach their full potential.

We encourage applications from people of all backgrounds and identities, and provide reasonable accommodations to ensure an accessible recruitment process. If you need support or adjustments during your application, let us know—we’re here to help you succeed.

The Talent Acquisition Team at PMI will be grateful for CVs/Resumes to be submitted in English.