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.
At Roche, we advance science so that we all have more time with the people we love. Our Clinical Safety organisation is dedicated to delivering meaningful improvements to patients through medically-differentiated therapies. In this role, you will provide essential safety science and pharmacovigilance support to molecules across the Roche portfolio, ensuring the highest standards of participant safety and data reliability.
As a Safety Director, you will provide vital safety science and pharmacovigilance support across our diverse portfolio, ensuring the safety of our participants and the integrity of our clinical data from early development through to marketed products.
In this pivotal role, you will act as a recognized expert in drug safety, applying strong self-leadership to manage complex safety profiles.
The Opportunity:
Working under the matrix leadership of the Safety Strategy Leader (SSL):
Develop and maintain an expert understanding of product safety profiles and drive the overarching safety strategy for assigned molecules.
Drive signal detection and management activities, ensuring proactive identification and evaluation of safety issues.
Take independent responsibility for risk management activities, including the preparation and maintenance of Risk Management Plans, Risk Evaluation and Mitigation Strategies, and labelling documents.
Review clinical protocols, Investigator’s Brochures (IB), and informed consent forms to ensure alignment with safety strategies.
Lead safety science contributions for global regulatory filings, including INDs, NDAs, and MAAs.
In partnership with the SSL, you will support the presentation of important safety issues to internal and external review and governance committees, as needed.
Work cross-functionally in a global matrix environment, mentoring colleagues and coordinating with external vendors to ensure excellence in safety science.
Act as a functional business process owner or subject matter expert to improve our safety science practices.
You may be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
Cross-functional Collaboration: Partner with functions including Clinical Science, Regulatory, Data Science and Clinical Operations and Surveillance teams to ensure seamless execution of business initiatives.
Mentor & Lead: Act as a subject matter expert within the function, coaching junior scientists
Who You Are:
You are a proactive, structured thinker who thrives in a global matrix environment that is passionate about patient safety and possesses the analytical rigour to interpret complex data, ensuring that every decision we make is backed by sound scientific evidence. At Roche, you will find a culture that values your expertise and offers you the space to grow as a leader in safety science.
A qualified healthcare professional or a Life Sciences graduate (a PhD, MSc, or PharmD is a distinct advantage) and bring 7+ years of experience.
Bring extensive experience in clinical drug development within the biopharmaceutical industry, ideally with a focus on clinical safety.
You possess a broad understanding of PV and clinical risk management, including GVP, GCP, and CTR requirements.
Proven track record of leading and influencing in a global matrix environment, even without formal authority.
Skilled at applying complex data analysis and statistical methods to evaluate and present scientific data with clarity
An effective communicator and presenter, capable of summarising complex decision points for senior leadership.
Relocation Benefits are not available for this job posting.
#MQRS
The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.We use artificial intelligence to screen, assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
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.