Major Accountabilities
* End to end management of assigned pharmacovigilance processes across Novartis Divisions -Responsible for ensuring compliance to global regulatory requirements with maximum efficiency -Lead assigned cross functional patient safety projects -Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally -Develop and maintain training material and communications for Novartis group and third party associates -Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements -Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases) -Analyze the impact of other process and organizational changes -Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements.
* In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions.
* Measure effectiveness of actions taken -Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
* Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements.
* Mentor and train new starters -Distribution of marketing samples (where applicable)
Key performance indicators:
* Adherence to Novartis policy and guidelines -Project & stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections
Minimum Requirements:
Work Experience
* Functional Breadth.
* Managing Crises.
* People Challenges.
* Project Management.
* Operations Management and Execution.
* Collaborating across boundaries.
Skills:
* Databases.
* Employee Training.
* Pharmacovigilance.
* Project Management.
* Reporting.
* Safety Science.
Languages :
* English.