Global Patient Safety Physician
- Remote, Home Office, Remote, Home Office, United States
- Employees can work remotely
- Department: Global Patient Safety
Aurinia exists to make a difference. From the earliest days of the company, we’ve seen the potential in applying a creative, thoughtful and responsible approach to developing and commercializing therapies with a goal of changing the course for patients in disease areas that have been historically challenging to address. We Care, for our patients and our employees.
We are currently commercializing a treatment of lupus nephritis (LN) in the United States and preparing for potential commercialization of this compound in the EU, UK, Russia and Japan with Otsuka Pharmaceutical. We are also looking to leverage our internal capabilities to advance additional innovative therapies which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.
- Ensure effective, proactive, continuous medical management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met.
- Act as a member of the Global Product Team and Clinical Development Team for one or more products, as required and as delegated and as such be the contact person for relevant medical safety-related deliverables, issues and questions in relation to this (these) product(s).
- Support the risk management activities for the respective products, ensuring high quality medical safety input for all benefit- risk assessments.
This requires effective medical, technical, and scientific expertise in safety data collection, evaluation, medical interpretation, and communication and global PV regulations and guidance's.
- Ensure proactive safety and risk management for all assigned products through an ‘Integrated Safety Sciences’ collaborative approach, implement proactive safety and risk management strategies, agreed cross-functionally with product team colleagues, for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions
- Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy
- Serve as primary Aurinia GPS Lead in the development of the Risk Management Plan for assigned products, as applicable
- Support safety decision- making for benefit-risk assessment
- Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data
- Provide medical support (and leadership as delegated by the Head of GPS) for all safety components of regulatory submissions, health authority safety-related questions, and periodic safety reports (PSURs, PBRERs, DSURs)
- Contribute effectively in internal interactions and cross-functional teams
- Deliver medical safety assessments as required, e.g. in the evaluation of the risk and impact of product quality complaints
- Ensure that the Head of GPS, and thereby Aurinia senior management, are kept informed of any new data that might impact the benefit-risk of assigned Aurinia products
- Ensure up-to-date oversight of the emerging safety profile for all assigned Aurinia products
- Ensure continuous assessment of all new safety information, through the ‘Integrated Safety Sciences’ collaborative approach
- Lead signal detection and signal evaluation activities for assigned products
- Collaborate closely with cross-functional teams on the safety of patients participating in clinical studies including the operation of Data Safety Monitoring Boards
- GPS Product Leader role for the assigned product(s), ensuring appropriate medical safety input to all safety-related issues and questions
- Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decisions are made
- Contribute effectively in external interactions, eg SMCs/IDMCs; preparation of the medical safety aspects for, and attendance at, regulatory authority meetings; interactions with external advisers or opinion leaders; collaboration with colleagues from partnership companies for co-development or co-marketing etc
- As delegated by Head of GPS, provide medical safety expertise for due diligence activities, preparing an integrated safety assessment for consideration by senior management
- Contribute to the overall success of Global Patient Safety and Aurinia
- Provide therapeutic and product-specific training within GPS and more widely within the company and for external vendors as required
- Provide relevant subject matter expertise as required for audits and inspections, including any necessary pre-work in preparation for the audit/inspection, interviews with auditors/inspectors, as required, and follow-up on any subsequent actions and CAPAs
- Physician with proven clinical ability exercising medical judgment as a physician
- Fluent in written and spoken English
- Industry experience in either clinical development or pharmacovigilance
- Knowledge of product development processes and experience of cross-functional team work
- Solid working knowledge of pharmacovigilance legislation
- Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file
- Competent medical judgment in safety decision-making
- Competent team player with excellent networking and influencing skills
- Ability to prioritise own workload, work under pressure and achieve strict timeline targets
- Excellent verbal and written communication skills
- Problem-solving approach – solution- and results-orientated
All candidate information will be kept confidential according to EEO guidelines