The Head of Patient Safety successfully leads a Therapeutic area / Development unit (TA / DU) of the Medical Safety organization to improve patients’ lives and impact on overall Novartis results through robust safety evaluation expertise and medical innovation.
Ensures optimal patient safety as first priority by developing a state of the art safety strategy, driving medical safety processes and capabilities and having accountability for safety compliance within the TA / DU.
Is responsible for building an efficient team within the TA / DU and attracting, retaining and developing talents.
Major Accountabilities include :
1. Manages an efficient and successful TA / DU Medical Safety organization, which provides robust medical and science-driven contribution to Benefit-
Risk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide. Ensures optimization of Benefit-
Risk profile for all Novartis projects / products with Duty of Care assigned to the TA / DU as appropriate.
2. Enhances scientific and clinical experience of Medical Safety physicians / scientists through continuous training and coaching.
Participates in building the talent pipeline for key roles in Medical Safety. Responsible for attracting, retaining and developing talents within TA / DU.
3. Prepares safety objectives and evaluates and manages performance of the Medical Safety associates within the TA / DU.
4. Accountable for the delivery of high quality, timely and standardized Medical Safety deliverables across the TA / DU.
Provides content guidance and Line Function approval as needed for all safety documentation prepared by the Medical Safety associates within the TA / DU.
Establishes and maintains common global processes and guidelines for Medical Safety assessment, analysis, and compliance within the TA / DU, including documented guidance for coding and the assessment of causality / expectedness for adverse event reports as required.
5. Ensures that Medical Safety signals from aggregate data are identified promptly and communicated / escalated appropriately, including oversight (as appropriate) of use of signal detection tools and other in silico applications and / or of safety intelligence sources for potential product signals.
6. Maintains a close collaboration with the EU QPPV by proactively escalating potential safety issues / changes that affect the Benefit-
Risk profile of the assigned product portfolio to the EU QPPV. Reviews PSURs and RMPs on behalf of QPPV as a delegated activity when required.
7. Leads and / or coordinates as appropriate the preparation of medical stewardship data / information for Novartis boards, crisis management teams, and Health Authorities for TA / DU safety issues.
8. Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues within CMO&PS and those from other functions, e.
g. Clinical Development, Medical Affairs, Regulatory Affairs, Medical Information, Biostatistics, Quantitative Safety & Epidemiology, Clinical Pharmacology, QA, BD&L and NIBR, as well as externally with expert panels and other scientific contacts.
9. Represents Novartis medical safety at outside organizations like CIOMS, PhRMA, etc.
10. Identifies external consultants on safety issues, as appropriate, when internal resources may be insufficient or when third party advice is desirable.
11. Ensure adequate and proper management of resources to support all projects and maintain business continuity within the TA / DU.
12. Is responsible for ensuring appropriate in-licensing clinical safety evaluation and alignment.
13. Provides support as needed for licensing activities, regulatory authority inspections and for project / product recall activities.
14. Provides input in development of innovative clinical safety methodology and promotes operational excellence and process simplification.
15. Deputize for the Global Head of Medical Safety as required for specific activities.
Ideal candidate's background :
Master of Public Health in Epidemiology (or equivalent).