local safety officer.

Nominated responsible person for pharmacovigilance as notified to the local Health Authorities,

Implement and maintain a pharmacovigilance system for the company products authorized in the territory and ensure compliance with applicable regulatory and company requirements,

Identify and clearly articulate evolving local needs (regulation changes, eco-system changes, etc.) impacting Patient Safety and as required work collaboratively with corporate Patient Safety teams to develop and implement solutions,

Maintain quality management system related to pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs,

Knowledge of product safety risks to act proactively and independently with local stakeholders and proactively escalate local safety issues to the Safety Leads as appropriate,

Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Quality Assurance,

Participate in and manage pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation of respective Corrective,

Actions Preventive Actions,

Ensure that all information relevant to the benefit/risk balance of the products is reported to Patient Safety,

Participate in product launch strategic meetings and ensure safety related reporting trainings,

Ensure that staff managing safety activities for or on behalf of the affiliate have the appropriate qualification and training,

Ensure that a pharmacovigilance training is provided to any local employees and applicable Vendors as applicable,

Ensure that the local safety organizational charts are kept current and any changes in the local staff are communicated to corporate patient safety.