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, 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 Pharmacovigilance (PV) organization, including preparing action plans for leadership endorsement. Ensures oversight of managing Patient Safety Quality Issues and Quality Events in AQWA / 1QEM.
Your key responsibilities include, but are not limited to:
1. Oversight and trending of the following areas:
* Receipt of Quality Issues and Quality Events
* Entry into AQWA / 1QEM
* Timely completion of investigations
* Implementation of appropriate CAPAs with supporting evidence
* Completion of effectiveness checks
* Timely closure in AQWA / 1QEM
1. Drive development of actionable insights and mitigation plans to identify and act on opportunities for improvement early.
2. Lead and support strategic risk management projects related to the Novartis Vigilance System.
3. Develop and maintain guidance documents and training materials to educate Patient Safety staff on handling Quality Issues & Events.
4. Monitor compliance with Quality Issue & Event handling processes and develop strategies to address deficiencies.
5. Collaborate with Compliance, Process Excellence, QPPV Office, and other functions to produce metrics and trend analyses to identify risks affecting the Vigilance System and CMO & PS organization.
6. Work with global functions and third parties to establish and meet joint accountabilities.
7. Develop and maintain procedural documents, including ownership of relevant PSMF sections and annexes.
8. Review emerging regulations, assess impacts, and implement process changes to ensure compliance.
9. Serve as a subject matter expert during audits and inspections, lead responses to findings, and oversee corrective actions.
10. Prepare reports and presentations on risk assessments for governance teams and escalate key findings appropriately.
11. Support the management of the Operational Metrics & Risk Committee 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 to interact at all levels.
* Excellent negotiation, presentation, and communication skills, with the ability to operate effectively internationally and cross-functionally.
* Strong analytical skills.
* Ability to mentor and coach others.
Educational Background:
PharmD, MSc in Life Sciences, or equivalent.
Commitment to Diversity & Inclusion:
Novartis is dedicated to fostering an inclusive work environment and diverse teams that reflect the communities we serve.
Accessibility and Accommodation:
Novartis provides reasonable accommodations for individuals with medical conditions or disabilities during recruitment and employment processes. If needed, contact us with your request and contact information, including the job requisition number.
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