Senior Safety Medical Director — Roche
- Location
- Mississauga
- Contract
- full-time
- Posted
- 16 days ago
Role overview
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.
- 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.
- due to medical qualifications:
- Interpret emerging safety data in the context of clinical medical practice experience and define safety questions/issues requiring specific clinical medical safety assessments.
- Advise on and interpret how risks may affect the overall clinical risk-benefit balance, considering real-world clinical practice.
Main responsibilities
- due to medical qualifications:
- Interpret emerging safety data in the context of clinical medical practice experience and define safety questions/issues requiring specific clinical medical safety assessments.
- Perform medical practice impact assessments for product quality safety issues.
- Determine potential clinical medical impact of non-clinical safety findings and interpret associated product risks.
- Make formal company medical assessments regarding the causal relationship between reported events and treatment (e.g., for Individual Case Safety Reports).
- Review clinical study plans, protocols, and documentation to ensure appropriate design and feasible risk management measures consistent with current clinical medical practice. Who you are: You bring a fo
What the company offers
- Advise on and interpret how risks may affect the overall clinical risk-benefit balance, considering real-world clinical practice.
Company and context
- As a Senior Safety Medical Director at Roche, you'll be a recognized expert and strategic leader in drug safety, driving safety strategy for our most complex molecules while building organizational capability across the Clinical Safety organization.
- You'll provide expert mentorship to colleagues, lead high-stakes regulatory submissions, and represent Roche's safety expertise to regulatory authorities, governance committees, and senior leadership.
- This role combines deep technical expertise with strategic influence.
- This is the perfect opportunity for a safety leader ready to shape the future of drug development and drive organizational excellence. The Opportunity:
- Takes the lead in defining, owning, progressing, and guiding the defined safety strategy for their program(s)
- Accountable for establishing and maintaining the company position on the safety profile and shaping the proactive patient risk communication and risk management strategy.
- Must provide an objective and neutral position as a safety professional, even when facing conflicting business priorities or viewpoints.
- Is the expert content reviewer for safety aspects and must be consulted for safety profile decision-making across the product lifecycle (e.g., updates to the Investigator’s brochure (IB)/safety label, Integrated Safety Management Plan/Risk Management Plan (RMP)).
- Leads the development of the safety strategy by providing input into clinical development programs, Target Product Profiles (TPPs), Integrated Evidence Plans (IEPs), health technology assessment (HTA) dossier, and launch strategies.
- Provides critical safety input to inform decision-making on clinical development plans and individual study designs.
Additional details
- Join Roche, where every voice matters.
- This is the perfect opportunity for a safety leader ready to shape the future of drug development and drive organizational excellence.
- Responsibilities due to medical qualifications:
- Review clinical study plans, protocols, and documentation to ensure appropriate design and feasible risk management measures consistent with current clinical medical practice.
Notes and original content
- The Position
- The Opportunity:
- Who you are:
- You bring a fo
Questions about this listing
What salary does Roche offer for this role?
Roche lists CHF 85'500 - 129'500 gross per year for this position in Mississauga. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
