Safety Director

Roche•Mississauga, ON

About The Position

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.

Requirements

A qualified healthcare professional or a Life Sciences graduate (a PhD, MSc, or PharmD is a distinct advantage).
7+ years of experience.
Extensive experience in clinical drug development within the biopharmaceutical industry, ideally with a focus on clinical safety.
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.

Nice To Haves

PhD, MSc, or PharmD is a distinct advantage.

Responsibilities

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.
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.
Support non-molecule projects, due diligence evaluations and other projects as needed.
Partner with functions including Clinical Science, Regulatory, Data Science and Clinical Operations and Surveillance teams to ensure seamless execution of business initiatives.
Act as a subject matter expert within the function, coaching junior scientists.