Risk Management 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 resolving legal liabilities and ensuring compliance with government regulations. Ensures accurate receipt, maintenance, and assessment of product labeling. Reports events or reactions as required by regulatory agencies, including adverse events data from clinical trials, spontaneous or solicited sources, and periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activities and post-marketing surveillance.

About the Role

The Risk Management Manager leads activities to identify and categorize risks that impact the Vigilance system and the broader Pharmacovigilance (PV) organization, preparing action plans for leadership endorsement. Ensures oversight of Patient Safety Quality Issues and Quality Events management in AQWA / 1QEM.

Your key responsibilities include :

• Oversight and trending of the following areas :
• Receipt of Quality Issues and Quality Events
• Entry into AQWA / 1QEM
• Timely investigation completion
• Implementation of appropriate CAPAs with evidence
• Effectiveness checks completion
• Timely closure in AQWA / 1QEM
• Developing actionable insights and mitigation plans to facilitate early identification and action on opportunities for improvement.
• Leading and supporting strategic risk management projects within the Novartis Vigilance System.
• Preparing and maintaining guidance documents and training materials for Patient Safety staff regarding Quality Issue & Quality Event processes.
• Monitoring compliance with handling processes and standards; addressing deficiencies through strategic initiatives.
• Collaborating with Compliance, Process Excellence, QPPV Office, and other functions to generate metrics and trend analyses to identify risk areas.
• Working with global functions and third parties to establish and meet joint accountabilities.
• Leading development and maintenance of procedural documents, including ownership of relevant PSMF sections and annexes.
• Reviewing emerging regulations, performing impact assessments, and implementing process changes to ensure compliance.
• Acting as a subject matter expert during audits and inspections, leading response preparations and corrective actions.
• Preparing reports and presentations on risk assessments for governance teams and escalating key findings appropriately.
• Supporting operational metrics and risk committee management, including scheduling, agenda preparation, and action follow-up.

Minimum Qualifications :

Educational Background : PharmD, MSc in Life Sciences, or equivalent.

Commitment to Diversity & Inclusion :

Novartis is dedicated to fostering an inclusive, diverse work environment that reflects the patients and communities we serve.

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