Patient Safety Group Manager

-Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.

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
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• 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.