Medical Safety Director

Roche•Mississauga, ON

1d•Onsite

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 Medical Safety Director, you will play a pivotal role in our Safety organisation, providing essential safety science and pharmacovigilance expertise across our diverse portfolio. You will be responsible for ensuring the safety of our trial participants and the reliability of our data, directly impacting how we deliver life-changing medicines to patients.

Requirements

7+ years of experience
Formal medical qualifications (e.g. MD; MB BS; MB ChB) with post-graduate clinical experience in relevant medical specialties.
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.
Effective communicator and presenter, capable of summarizing complex decision points for senior leadership.

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.
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.
Acting in a formal capacity as the assigned medically-qualified approver/signatory for any relevant safety-related documents where there may be a regulatory and/or legal requirement for an assessment or approval to be provided by a person who holds formal medical qualifications in a given area of clinical practice, or in a given territory.
Interpretation of emerging safety-relevant data, in the context of experience gained whilst practicing in relevant areas of clinical medicine/healthcare.
Performing medical practice impact assessments in the context of product quality safety issues (e.g. as part of defined activities outlined in PT-managed processes that require formal assessment by medically qualified individuals).
Determining the potential clinical medical impact of non-clinical safety findings, and/or the interpretation of potential product risks associated with such findings, in the context of current external clinical practice.
Providing advice and interpretation of whether/how risks may impact the overall clinical risk-benefit balance of an asset, in the context of typical clinical medical.