Roche
Senior Safety 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
- expert-level understanding of scientific aspects of safety, pharmacovigilance, and clinical/patient risk management with demonstrable knowledge of GVP, GCP, and CTR 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
- Experience across all lifecycle stages
Nice to have
- NDA/BLA filing experience strongly preferred
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
- A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous.
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.