Description:
The purpose of the role is to work with our clients to understand their needs, offer advice, solve problems, manage change, and improve efficiency.
Major Accountabilities
- Responsible for global pharmacovigilance strategy and team management and for compliance with safety regulations including efficient monitoring of all safety requirements worldwide.
- Responsible for global and in countries worldwide all PV operations including application of uniform standards, policies and procedures and metrics related to procedures.
- Drive strategy, develop and maintain global and local systems, processes and procedures for safety processes and collection and follow-up of adverse events and other relevant safety information to assure worldwide regulatory requirements can be met and needs are satisfied for marketed and development compounds.
- Responsible for innovation and technology strategy and for acquisition, maintenance and continuous enhancement of the global safety database and Patient Safety IT systems to drive digitalization and technological transformation
- Responsible for a well-functioning vigilance system & regulatory compliance with device vigilance regulations worldwide.
- Monitor and audit drug, biologics or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports.
- Interface with worldwide Health Authorities and external stakeholders for new worldwide safety regulations, on safety and compliance related issues and worldwide Pharmacovigilance inspections.
- Ensure compliance with the corporate's global and local procedures, national and international regulatory requirements in any assigned larger Region / Countries.
- Leading PVSO Hyderabad site and operational management of all PS Sites across divisions; responsible for global workload distribution and assignment of global projects.
- Adapt organization to clients vision of future drug development and enhance efficiency, productivity and robustness of operations through innovative system and Job Purpose
- Management of all external service providers (ESPs) supporting Patient Safety globally across divisions, responsible for global governance and accountable for contractual, operational and financial performance of ESPs.
- Leading transfer of global and local activities from high cost to low-cost countries and ESPs in alignment with the overall objectives and long-term goals of the Patient Safety organization.
- Accountable for resource planning and management (headcount and budget) for all PS functions and locations across divisions. Review and challenge resource requests and expenditures in order to meet budget and headcount targets.
- Manage headcount requests, staffing activities with Human Resource (HR) representatives and monitor against headcount targets. Work with PS Function Heads in close collaboration with HR to ensure recruitment of top talent, completion of performance management/HR procedures, and optimal resource deployment and reallocation within and across PS.
- Accountable for managing global Patient Safety internal and external financial requirements and budget across divisions and being main contact for Finance. Provide consolidated latest estimates on current annual budget and for future annual budgets. Identify issues and propose mitigating plans to facilitate decision making and prioritization of activities.
- Responsible for leading Patient Safety Operations, Training, Project Management, Global Patient Safety Alliance and Countries and Regions teams.
- Accountable for culture, talent and career development of direct reports and teams, including performance management. Contribute to talent and career development of PS staff through active participation in on-boarding, training and mentoring activities.
- Drive and manage change / adjustment of organizational structure and processes
- Responsible for overseeing both strategic and day to day perspectives of operational activities by working closely with Global Head CMO & PS and leadership team. Responsible for overseeing licensing agreement activities and for managing all PS contracts with external parties.
- Represent CMO & PS on global cross-functional and cross-divisional business process, performance, or Clinical Development system improvement initiatives.
- Represent Global Head of CMO and PS on all pharmacovigilance, strategy and operational issues. Manage flow of operational information as needed to/from other departments.
- Represent PS function as a leader in internal and external meetings and influence the external environment as an industry vigilance thought leader
- Chair the Innovation and Projects Governance Board (IPGB) and be accountable for the compliance of the IPGB to the ISO 9001 standard.