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 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 activities and post-marketing surveillance.

About The Role

The Risk Management Manager leads activities and initiatives designed to identify and categorize risks that could impact the Vigilance system and the broader Pharmacovigilance organization. Responsible for preparing action plans for leadership endorsement and overseeing management of Patient Safety Quality Issues and Quality Events in AQWA / 1QEM.

Your key responsibilities include :

• Oversight and trending of Quality Issues and Quality Events, including their entry into AQWA / 1QEM, investigation, CAPA implementation, and closure.
• Developing insights and mitigation plans to address opportunities for improvement.
• Leading strategic projects related to Risk Management of the Vigilance System.
• Creating guidance documents and training materials for Patient Safety staff.
• Monitoring compliance with handling processes and standards, addressing deficiencies.
• Collaborating across functions to produce metrics and trend analyses to identify risks.
• Supporting regulatory compliance and acting as a subject matter expert during audits and inspections.
• Preparing reports on risk assessments and escalating key findings.
• Managing the Operational Metrics & Risk Committee activities as Secretary.
• Minimum 4 years of experience in pharmaceutical industry, especially pharmacovigilance.
• Project management experience and ability to lead work groups.
• Strong interpersonal, negotiation, presentation, and communication skills.
• Analytical skills and ability to mentor and coach.

Educational Background

PharmD, MSc in Life Sciences, or equivalent.

Languages

Why Novartis?

We aim to improve and extend people’s lives through innovative science, digital innovation, diversity, and collaboration. Join us to create a brighter future.

Commitment To Diversity & Inclusion

We are committed to an inclusive environment and diverse teams.

Accessibility and accommodation

We provide reasonable accommodations for individuals with medical conditions or disabilities. Contact : with your request and contact info, including the job requisition number.

J-18808-Ljbffr

J-18808-Ljbffr