Associate Safety Director

Roche•Mississauga, ON

1d•Remote

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.

Requirements

5+ years of experience
Degree in Life Sciences or qualified healthcare professional (PhD, MSc, or PharmD preferred).
Extensive experience in drug development, with a significant track record specifically within drug safety or pharmacovigilance.
Deep understanding of GCP, GVP, and the end-to-end clinical trial lifecycle.
Skilled at applying complex data analysis to interpret and present scientific data with clarity and impact.
Excel at influencing stakeholders and building partnerships across global, remote teams.
Proven ability to manage high-priority projects and act as a subject matter expert in safety science activities.

Nice To Haves

Proactive and independent safety professional who thrives in a collaborative, matrix environment.
Growth mindset and willingness to challenge the status quo to bring agile, innovative approaches to our safety science practices.

Responsibilities

Provide safety oversight across the development and marketed portfolio.
Deliver safety science and pharmacovigilance support, from early and late phase development through post-marketed signal and risk management.
Develop and maintain an understanding of the safety profile for assigned products, providing clinical input into the interpretation of emerging safety data.
Contribute to aggregate case analysis and reporting activities including preparation of periodic safety reports (ie. DSUR, PBRER).
Drive signal management activities, including signal detection and assessment, and contribute to risk management activities (e.g.RMPs/REM) and provide advice and interpretation of whether/how risks may impact the overall clinical risk-benefit balance of an asset.
Support the preparation and review of safety sections for regulatory filings (IND, NDA, MAA) and labeling documents like the Company Core Data Sheet, or Investigator’s Brochure.
Represent Clinical Safety on development study teams and prepare and/or review safety sections of study documents (e.g. protocol, Informed consent, etc).
Contribute to and/or and provide input into internal or external Drug Monitoring Committees.
In partnership with the SSL, support presentation of safety issues to the internal Safety governance committee.
Coordinate with vendors and may act as a functional business process owner or subject matter expert to improve our safety science practices.
Partner with functions including Clinical Science, Regulatory, Data Science and Clinical Operations teams to ensure seamless execution of business initiatives.
Act as a subject matter expert within the function, coaching junior scientists.