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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob SummaryAt Innovative Medicines, we are seeking a highly skilled professional to lead our Global Aggregate Reports & Risk Management team. As the Group Head, you will be responsible for developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.About the RoleThe Group Head, Global...
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob Title: Group Head, Global Aggregate ReportsAbout the Role: We are seeking a highly skilled and experienced professional to lead our Global Aggregate Reports Risk Management team. As the Group Head, you will be responsible for developing and implementing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority...
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Global Risk Management Lead
hace 3 semanas
Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob Title: Group Head, Global Aggregate ReportsAbout the Role: We are seeking a highly skilled and experienced professional to lead our Global Aggregate Reports and Risk Management team. As the Group Head, you will be responsible for developing and implementing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned...
Global Head, Aggregate Reports and Risk Management
hace 2 meses
The Global Head, Aggregate Reports and Risk Management, leads a team of Senior Risk Management and Aggregate Reports Specialists in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the products and supported by complex stakeholder matrices.
Key Responsibilities- Responsible for timely high-quality deliverables either through direct involvement in processes or through assignments taking into consideration individual workload, experience, location, business needs, and individual development needs.
- Interacts with Global Product Teams and Functions to ensure proper prioritization of programs and assign adequate resources.
- Aligns the support provided by Senior Risk Management and Aggregate Reports Specialists to the Global teams in developing and maintaining the Safety Risk Management Plans, Risk Management strategy, and Aggregate Reports with business rules, regulatory guidance, and company standard operating procedures.
- Responsible for recruiting, developing, retaining Senior Risk Management and Aggregate Reports Specialists, and developing and implementing an onboarding program for new hires.
- Provides operational and strategic guidance on Risk Management and Aggregate Reports processes, policy, templates, and training.
- Responsible for Risk Management and Aggregate Reports team objectives according to company and department priorities, development plans, and ongoing feedback on performance of direct reports.
- Member of the Risk Management and Aggregate Reports Leadership Team.
- Collaborates with the Global Head, Aggregate Reports and Risk Management, in setting the department's objectives and achieving them.
- Advises and influences the organization regarding Aggregate Reports and Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide, as well as for lifecycle management, by close connection with stakeholders and industry peers.
- Guides a cross-functional matrix in the development of tools for Risk Management Plan preparation, implementation tracking, working practices, and guidelines, implementation of regulatory guidance, and Safety Risk Management project management.
- Acts as Risk Management and Aggregate Reports Subject Matter Expert (SME) in inspections and audits, including handling of pre-inspection/audit requests, participating in interviews with inspectors/auditors, and supporting CAPAs.
- Acts as Risk Management and Aggregate Reports SME for assigned collaborations at early stages of partnerships, including integrations, mergers, and acquisitions.
- Influences these collaborations beyond Patient Safety, in global and local cross-functional and cross-divisional aspects of Risk Management, including Regulatory Affairs, Marketing, Countries, which impact worldwide launches.
- Represents Risk Management and Aggregate Reports in MSRB, GLC, GPTs, and SMTs, and provides expert opinion as required.
- Evaluates the impact and ensures compliance in collaboration with OPEX of worldwide regulations and industry practices on current Risk Management and Aggregate Reports plans, strategy, processes, and tools.
- Drives the internal alignment on the company position with multiple functions and boards involved.
- Oversees the Global Teams' strategies for Risk Management and Aggregate Reports related responses to Health Authorities.
- In collaboration with OPEX and the Risk Management and Aggregate Reports office, designs, develops, and maintains metrics to monitor quality of Risk Management Plans and Aggregate Reports, and escalates to Head of department, QPPV, PS&PV leadership, and cross-functional boards any potential risk and issues.
- Provides input into the development of regular and up-to-date Risk Management and Aggregate Reports training to the organization, including SMT/GPTs, Medical Safety, Regulatory, Quantitative Safety and Epidemiology, Clinical, Medical Affairs.
- Deputizes for the Global Head, Aggregate Reports and Risk Management, including MSRB for Risk Management and Aggregate Reports related aspects, and strategic initiatives.
- Deputizes for other Group head when required, supporting their team.
