US-NJ, Director US Oncology Safety Risk Management 220803BR-MZ
Director US Oncology Safety Risk Management
East Hanover, NJ
Research & Development
Strategically partner with internal and external stakeholders to provide skill center of excellence for Risk Management Plans (RMPs) and Risk Evaluation and Mitigation strategies (REMS) that will position Novartis as the industry leader in innovative, effective safety risk management.
1. Serves as the safety risk expert on project/product teams throughout the product life cycle and contributes to the development and implementation of innovative, evidence-based risk management solutions, including enhanced pharmacovigilance and risk minimization activities that will ensure optimized benefit with minimized risk.
2 .Provides strategic input on product risk evaluation and REMS elements to optimize safe use.
3. Drives execution of REMS development according to agreed upon strategies
4. Deliver REMS and Safety Risk Management regulatory policy insight across US Oncology Medical & DRA teams.
5. Ensures compliance with Standard Operating Procedures and Working Practices for RMPs and REMs.
6. Oversight of the tactical implementation and clinical monitoring of REMS commitments.
7. Provides the status of local implementation of the Global RMP/REMS commitments for Periodic Safety Update Reports (PSUR) and RMP/REMS updates.
8. Partner with the pharma organization risk management team and Patient Safety organization to work collaboratively towards addressing evolving needs
9. As US Oncology RMP manager, ensures compliance with Core RMP commitments from relevant CPO line units and ensure communication of consolidated input to global RMPs and Patient Safety
10. Develop monitoring process to track the assessments/metrics of REMS, in concert with DRA, and ensure compliance with reporting requirements to the FDA
11. Identify preferred external consultants/vendors to meet different REMS goals
12. Strategically partner with Global IMS, Epidemiology, DRA, US Oncology Medical and Global development and other functions to ensure that Global and US Risk Management strategies are aligned
13. Creates REMS and RMP training programs and delivers training to diverse audiences.
14. Takes the lead on any safety related activities e.g. audits, remediations
15. Partner with medical, contracts and patient safety organization to resolve questions, request for changes in template safety reporting language from institutions
Position will be filled at level commensurate with experience.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Medical Degree (MD), PharmD or PhD required.
At least 7 years in drug development in a major pharmaceutical company including 5 years in safety at an operational or medical position preferred.
Experience of REMs/RMPs preferred.
Experience in drug development, clinical trial methodology, regulatory requirements and scientific methodology.
Experience in preparation of clinical safety assessments and regulatory reports/submissions involving safety information.
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