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 and initiatives to identify and categorize risks impacting the Vigilance system and the broader PV organization, including preparing action plans for PS&PV leadership endorsement. Ensures oversight of Patient Safety Quality Issues and Quality Events management in AQWA / 1QEM.
Your key responsibilities include:
* Overseeing and trending areas such as:
* Receipt of Quality Issues and Quality Events
* Entry into AQWA / 1QEM
* Timely completion of investigations
* Implementation of appropriate CAPAs with supporting evidence
* Conducting effectiveness checks
* Timely closure in AQWA / 1QEM
* Developing actionable insights and mitigation plans for early opportunity identification and action
* Leading and supporting strategic Risk Management projects related to the Novartis Vigilance System
* Preparing and maintaining guidance documents and training materials for Patient Safety staff on Quality Issue & Quality Event processes
* Monitoring compliance with Quality Issue & Quality Event handling standards and addressing deficiencies
* Collaborating across functions to produce metrics and trend analyses to identify risk areas affecting the Vigilance System and CMO&PS organization
* Working with global divisions and third parties to establish and meet joint accountabilities
* Developing and maintaining procedural documents, including ownership of relevant PSMF sections
* Reviewing emerging regulations, assessing impacts, and implementing process changes for compliance
* Acting as SME during audits and inspections, leading response preparations and CAPA implementations
* Preparing risk assessment reports for governance and escalating key findings to leadership
* Supporting operational metrics and risk management meetings as Secretary, including scheduling, agenda preparation, and action tracking
Minimum Qualifications:
* At least 4 years of experience in the pharmaceutical industry, especially pharmacovigilance
* Experience in project management and leading work groups
* Strong interpersonal skills for interaction at all levels
* Excellent negotiation, presentation, and communication skills in an international environment
* Strong analytical skills
* Ability to mentor and coach team members
Educational Background:
PharmD, MSc in Life Sciences, or equivalent
Commitment to Diversity & Inclusion:
Novartis aims to foster an inclusive, diverse work environment that reflects the communities we serve.
#J-18808-Ljbffr