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

This role is to cover maternity leave initially for 12 months with possibility to extend the contract.

In this role you will ensure that our local Pharmacovigilance (PV) system is efficient effective and fully compliant with global Roche and local standards safeguarding our License to Operate. You will also ensure to actively drive patient safety strategies taking ownership of decision-making to deliver high-quality safety solutions in alignment with local Affiliate Patient Safety strategy and International Pharmacovigilance.

The Opportunity

Execution of safety-related activities relevant to the PV system through partnership with key local and global stakeholders such as Patient Safety Operations and Affiliate PV Net to ensure monitoring of the safety profile of Roche products and their safety risk management meeting regulatory requirements and ensuring license to operate.

Key areas of activities include:

• Individual Case Safety Reports (e.g. data collection)

• Pharmacovigilance Agreements (e.g. PVA Safety Data Exchange Agreement)

• Risk Management and Safety Communication (e.g. Direct Healthcare Professional Communication Risk Minimization Measures emerging safety issues)

• Studies Programs and other projects with PV implications

• Proactively identify opportunities to optimize the PV system

You will also be responsible to:

• Identify analyze and share safety insights by understanding disease areas (Roche portfolio patient journey) engaging with key stakeholders and ensuring timely proactive integration into Affiliate and global strategies

• Implement global safety solutions locally and execute product safety launch readiness activities

• Support the country-level risk management strategy to optimize patient outcomes in collaboration within relevant networks and ensure compliant and transparent PV communications (e.g. DHPCs) to healthcare professionals patients and external partners in collaboration with Medical Affairs and the cross-functional team

Who You Are

• Degree in Life Science or healthcare-related disciplines e.g. PharmD MSc BSc Nursing etc.

• Czech language at native level English fluency (spoken and written)

• Proven work experience (1 years) in pharmacovigilance in an affiliate setting preferably

• Demonstrated understanding of decision-making in the local & global PV ecosystem

• Experience in Medical Affairs Clinical Operations Medical Information or Clinical Safety is an advantage

• Proven proactive systems-based approach to defining outcomes and influencing local strategy

• Proven understanding of high level drug development commercial development and financial standing

• Build trusting relationships with internal stakeholders through clear effective and timely communication

• Demonstrated mindset of thinking beyond ones role and team to identify wider opportunities and impact

• Demonstrated leadership of tasks/projects with clarity by aligning daily priorities with global and local strategies while autonomously resolving obstacles within their discipline

• Experienced with processes during audits and inspections

• Self-aware and actionable upon feedback

• Demonstrated ability to fit into a high-performing culture where empowerment and accountability are key for reaching common team goals

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.