Risk Management Specialist
hace 3 semanas
Novartis, an inclusive employer and a member of the LGBTQ+ business community, seeks a Risk Management Manager to lead activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader PS&PV organization.
Key Responsibilities:- Monitor and audit the company's drug, biologics, or medical devices surveillance program, including the intake, evaluation, processing, and follow-up on adverse reports.
- Participate in the resolution of any legal liability and comply with government regulations.
- Ensure accurate receipt, maintenance, and assessment against product labeling.
- Report events or reactions as required by regulatory agencies, including adverse events data from clinical trials, spontaneous or solicited sources, periodic, and experience reports.
- Provide trending and safety signal detection and assessment.
- Support all clinical trial activity and post-marketing.
The Risk Management Manager will lead the development of actionable insights and mitigation plans to ensure that any opportunities for improvement are identified and acted upon as early as possible.
Lead and support strategic projects related to Risk Management of the Novartis Vigilance System.
Prepare and maintain guidance documents and training material to educate Patient Safety associates on the Quality Issue & Quality Event process.
Monitor compliance of the Patient Safety organization to Quality Issue & Quality Event handling processes and standards and where deficiencies are identified, develop and implement strategies to address these.
Collaborate with the Compliance, Process Excellence, QPPV Office, and other functions to produce metrics and complete trend analyses designed to identify areas of risk with impact on the Vigilance System and/or CMO&PS organization.
Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilities.
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