Roche
Senior Safety Medical Director
Mississauga · Director
Sponsorship not specifiedDetected 16 days ago
GCPData AnalysisProduct ManagementPharmacovigilanceCommunicationMentoringPublic Speaking
About the role
- 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.
- Also provides requisite oversight and expert review for safety components of regulatory authority submissions (e.g., IND, NDA, MAA).
Responsibilities
- 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.
- This is the perfect opportunity for a safety leader ready to shape the future of drug development and drive organizational excellence.
Requirements
- 10+ years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia
- preferably including at least 5 years of experience in a clinical drug safety-related role.
- Demonstrate expert understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.g. via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
- Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
- Strong presentation skills, effective at summarizing and presenting the key considerations and decision points and ability to effectively train others on departmental practices and processes
Compensation
- The expected salary range for this position based on the primary location of Mississauga is 148,568.00 and 194,995.50 of hiring range.
Benefits
- 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.
- Advise on and interpret how risks may affect the overall clinical risk-benefit balance, considering real-world clinical practice.
- 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.
Company info
- 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.
- 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.
This listing is sourced directly from Roche's careers page and normalized into a canonical job model.