Pharmacovigilance manager Russia & CIS

Salary:

Payment is negotiable

Published:

28.06.2016

Employment type:

City:

Moscow

Required experience:

Описание:

• Ensure appropriate liaison with peers and functional areas to fulfill safety obligations and promote Good Pharmacovigilance Practices
• Ensure consistency and compliance with all processes and procedures within Patient Safety
• Ensure safety legislation in the Region is monitored and procedures and expedited reporting rules are updated accordingly
• Liaise with Patient safety employees to ensure a coordinated approach and consistent case management, expedited and periodic reporting standards
• Subject Matter Expert in Adverse Event (AE) management and workflow elements
• Function as back-up for Case Management, periodic reporting and expedited reporting in the Region when needed
• Ensure the appropriate communication of safety issues with other internal functions and Global Patient Safety management
• Ensure completion of action items of GPS Quality Plan and Corrective and Preventive Actions (CAPA) within the required timeline
• Ensure Business agreements with respect to PhV are in place and up to date
• Ensure an out of hours process for AE management is in place as needed
• Ensure local Patient Safety Contacts are appointed where there is a national requirement
• Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)
• To have understanding on the roles and responsibilities of the EU Qualified Person
• Support and train all affiliate personnel in safety requirements and processes
• Train Business Alliance partners and/or Third Party Vendors on reporting requirements, as required
• Build close working relationships with other functions areas in affiliate (e.g. Clinical operations, sales/marketing, etc)
• Build close working relationships with affiliate Management and Global Regulatory Affairs, Global Patient Safety and Global Medical Communication
• Collaborate with external customers and be an active participant of the Regulatory and Pharmacovigilance Expert Network group of the Pharma Companies
• Lead, motivate and work with Patient Safety Group members in the Region
• Ensure optimal resource and workload management within the group
• Recruit, train and develop employees
• Assign job description and curriculum map to Patient Safety group members

Requirements:

• Higher education (medicine, pharmacy)
• Experience in Pharmacovigilance area 3-6 years
• Knowledge of Local legislation and regulation of Eurasian Economic Community
• English upper intermediate or fluent
• Excellent knowledge of MS Office
• Strategic thinking
• Excellent communication skills
• Initiative, result-oriented and well-organized
• Attention to details
• Adaptation and flexibility, ability to manage multiple tasks simultaneously
• Skill to work in team
• Adaptation and flexibility, ability to manage multiple tasks simultaneously
• Skill to work in team.