In a position with powerful influence over the clinical safety plans for products, this role demands an individual who can fully grasp a product profile and develop a safety strategy within the relevant context. Taking into account clinical protocols, study reports and investigation findings, your ability to align documentation with safety strategy will be crucial in developing product safety plans with substance and value.
Influencing decisions across product lifecycles and risk, you can expect to offer in depth contributions to regulatory authority submissions, safety reports and product data. You’ll be highlighting key issues to the Drug Safety Committee and Development Review Committees, delivering and supporting presentations for review and governance purposes. As a custodian of safety and risk standards, you’ll also provide support and detailed input on the safety components of Target Product Profiles, key claims and other lifecycle strategic planning documents
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
For the Senior level you will have completed an MD degree and post-graduate training with academic experience. You will also have specialty training and board certification or equivalent (current or past). Otherwise you will have a degree or similar equivalent and postgraduate level experience of drug safety and medical affairs experience, you’ll need a comprehensive appreciation of the clinical development process, especially through the lens of data analysis, interpretation and clinical relevance. A confident and competent leader, you’ll be naturally attuned to working with cross functional teams, either in academic or industry settings.
In return we offer a competitive salary plus the excellent benefits you would expect from a bluechip organisation, including a genuine interest in your development.
Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety