Director, Case Management and Aggregate Reporting

Director, Case Management and Aggregate Reporting is accountable for development and deployment of the Sandoz safety case management and aggregate reporting strategy in close collaboration with Head Patient Safety Operations & Compliance. This includes
Leading and developing team, responsible for oversight and control of all clinical trial and post marketing safety cases handled by Sandoz s and its strategic suppliers.
Leading and developing team, responsible for oversight and control of all aggregate reports handled by Sandoz s and its strategic suppliers.
Ensure compliance with reporting timelines and quality standards which are under the control of patient safety operations.
Manage strategic interfaces with other internal and external stakeholders (e.g., Global line function senior management, investigator sites, Vigilance Agreement Partners (VAP) to ensure consistent processes, efficient handling of safety case reporting, aggregate reporting, regulatory compliance, operational productivity, timelines, and quality of safety information

• Responsible for global compliance, quality, efficiency and management of post marketing & clinical trial safety cases and aggregate safety analysis/ reporting for products across Sandoz Group Portfolio.
• Create and implement a mindset of operational excellence t o strategically optimize business efficiency in alignment with Global objectives and vision. Lead global internal audits and Health Authority Inspections taking complete responsibility for inspection readiness and timely implementation of necessary corrective and preventive actions.
• Alert Sandoz leadership on awareness of any critical or major incidents, observations, and risks. Support and guide continuous improvement, quality, productivity, and innovation leveraging internal and external people, process and technology.
• Manage interfaces with VAPs to ensure that global VAP business expectations are consistently met. Responsible for assuring conformity with global procedures, process, and regulatory requirements for all associates of safety case management and aggregate team within Sandoz and strategic suppliers.
• Build high performing teams, recruits, develop, manage, coach and appraise the performance of direct and indirect reporting associates.
• Collaborate with Director Strategic Supplier Partnership input into developing and managing global supplier(s) budget and implementing precise and reliable forecasting of budget.
• Accountable for leadership, talent management, career development and performance management of direct reports and teams. Contribute to talent and career development of Sandoz patient safety India staff. Where required, act as Country Operational Manager for India based Sandoz patient safety associates.
• Drive and manage change / adjustment of organizational structure and processes. Deputize for Head Patient Safety Operations & Compliance in key global leadership forums representing internal and external forums including senior leadership meetings at Sandoz.

What you ll bring to the role: Essential Requirements:

• Graduate/ Postgraduate/ Doctorate degree in Life Sciences/ Pharmacy/ Medical Sciences or equivalent degree
• Ten years of pharmaceutical industry experience, preferably broad experience in pharmacovigilance, knowledge of drug safety regulatory requirements and general project management desirable.
• Seven years people management and development experience required. Global people management experience desirable.
• Demonstrated success in resource planning and management.
• Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills. Quality and focus oriented.
• Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.

Clinical Research, Clinical Trials, Regulatory Compliance, Safety Science, Team Management