Patient Safety (Pharmacovigilance) Partner - 15 Months Max Term Contract

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

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

• A patient-safety focused role
• A diverse and supportive team
• Agile way of working in a fully flexible work environment

A Patient Safety Partner delivers expert knowledge on the safety profiles of Roche medicines, defines how to manage risks to patients, and coordinates the pharmacovigilance (PV) system activities for the company.

The Patient Safety Partner is an expert on the safety profile of Roche products and oversees PV processes ensuring they fit for purpose and acts as subject matter expert for PV processes.

What you will be working on:
Your key responsibilities include but not limited to:

• Develops strategy, informs and trains internal and external stakeholders on Roche products’ safety profile and PV requirements
• Works as a business partner across all chapters and squads involved in activities that have PV implications
• Leads activities to ensure inspection readiness
• Oversees Individual Case Safety Report (ICSR) Processing and management of ICSRs from all relevant sources (solicited and unsolicited sources)
• Oversees reviews of PV Agreements, Safety Data Exchange Agreements (SDEAs) and other contracts with external third parties
• Ensures all safety information from internal/external stakeholders and vendors associated with Roche Products has been collected and reported as appropriate, which include but not limited to the following sources: Roche-managed studies / IIS, MAPs, Medicines Assistance, MI Atlas, Technical complaints/counterfeit related issues, CRM, local media and local literature monitoring, Regulatory reports, Service provider oversight
• Provides safety advice to internal and external parties to ensure advanced product knowledge and safety of medicines
• May act as back up LSR / TGA Qualified Person for PV / TGA PV Contact Person, Vendor point of contact

Who you are:
You have:

• Degree in pharmacy, other health disciplines, or life sciences
• Demonstrated experience in Pharmacovigilance (PV) or relevant experience in a GCP area preferred
• A thorough knowledge of GVP, ICH, GCP, TGA regulations, Medicines Australia Code of Conduct and other relevant regulations, standards and guidelines, Medical terminology - verbal and written and an existing proficiency with PV systems and tools (e.g. ARISg) is preferred

You are able to communicate in a concise and clear manner and are good at building strong collaborative relationships with key stakeholders.

This role is only open to candidates who have full eligibility to live and work in Australia.

We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team.

What we offer

Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders.

Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.

Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes.

We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration.

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.