Teva Dir Pharmacovigilance 

India, Karnataka, Bengaluru 

967172202

• The ICSR Global Operations Leader is accountable for the end-to-end execution of global ICSR operational activities, including oversight and proactive management of vendor-delivered services. Reporting to the Head of Systems Data Innovation (SDI) and IL Site Lead, this role is a key member of the global SDI leadership team.
• The role leads and ensures a high-performing global team, ensuring full compliance with internal procedures and regulatory requirements while driving continuous improvement across the ICSR lifecycle - from case intake to timely, high-quality data entry and submission. It is responsible for the day-to-day execution, monitoring, and optimization of ICSR processes, with a strong focus on operational efficiency, quality, and adherence to industry standards.
• As a senior leader, the ICSR Global Operations Lead plays a pivotal role in shaping and implementing SDI strategies in close partnership with SDI leadership, cross-functional collaborators, and both internal and external stakeholders. The role provides strategic direction on operational excellence, compliance, resource planning, and global team development.
• This leader is expected to bring an adaptive, innovative mindset - serving as a change agent who empowers the team, translates strategic vision into operational reality, and champions the value of safety case management across Teva and within the broader pharmacovigilance ecosystem. With direct responsibility for both people leaders and individual contributors, the role also includes mentoring, coaching, and developing talent across regions, with a special focus on supporting the growth and engagement of the PV India team in alignment with Teva’s global PV strategy.

1. Global ICSR Ownership & Compliance Leadership

• Serve as the Senior SME and global owner for end-to-end ICSR operations (post-marketing), accountable to meet or exceed the KPIs for ICSR quality, compliance, and operational delivery worldwide.
• Lead daily operational execution, ensuring timely case processing, proper prioritization, and resolution of workflow issues in collaboration with the relevant stakeholders.
• Contribute to the development, implementation, and maintenance of SOPs and WIs, ensuring adherence to international regulatory requirements and audit/inspection readiness.
• Oversee CAPAs, deviations, and regulatory updates for own area of responsibility, with full accountability for timely closure and continuous improvement.
• Process ICSRs in the global safety database from time to time (2-4 cases / week) - maintaining a close connection to real-time operations and reinforcing practical leadership.

2.Strategic Direction, Innovation & Process Excellence

• Define and execute the strategic roadmap for ICSR operations, aligned with Teva’s global PV vision, industry trends, and evolving regulatory expectations.
• Lead the development of robust real-time monitoring and forecasting models to support seamless execution, enhance case processing KPIs, improve operational visibility, and increase predictability and agility—shifting the organization from a reactive to a proactive, forward-looking approach.
• Champion innovation, leveraging advanced technologies such as automation, bots, and AI to drive efficiency, scalability, and simplification.
• Evaluate and enhance operating models to optimize resource use, compliance, and data quality.

3.Stakeholder Partnership & Cross-functional Engagement

• Act as the global point of contact for all stakeholder interfaces related to case intake, including Clinical Operations, Medical Affairs, and Quality.
• Establish and maintain strong, visible relationships with key partners to ensure a seamless flow of safety information and shared accountability.
• Lead and influence global working groups, forums, and cross-functional initiatives to drive alignment and best-practice adoption.
• Provide strategic insights and data to PV core leadership team to support decision-making and long-term planning.

4.Vendor & Partner Management

• Own the global vendor relationship for ICSR processing activities, including selection, performance oversight, and contractual adherence.
• Define and track vendor KPIs, conduct regular reviews, and drive accountability for quality, compliance, and operational excellence.
• Foster transparent, proactive communication with vendors and external partners to ensure aligned expectations and continuous performance improvement.

5.
Team Leadership, Development & Engagement

• Lead, mentor, and develop a high-performing global ICSR operations team with clear goals, IDPs, and accountability structures.
• Promote a culture of ownership, innovation, and continuous improvement across all team members.
• Address people-related matters proactively and partner with HR and site leadership to ensure engagement, clarity of roles, and talent growth.
• Align team capacity and structure with business needs to ensure readiness and resilience.

• Minimum Master's degree in Life Sciences or another related field.
• Minimum of 10 years of experience in pharmacovigilance with strong knowledge of ICSR lifecycle and regulatory requirements.
• Minimum of 5 years of managing global teams and complex projects.
• Experience in inspections/audits and readiness activities is a strong advantage.
• Fluent in English.