Pharmacovigilance Country Head PE/VE

Collects adverse event data on all marketed products and those in development. Implements and oversees adverse event processes and databases. Ensures regulatory compliance for both expedited and periodic reports. Provides integrated strategic safety expertise to clinical development programs. Performs active pharmacovigilance with rapid identification and analysis of safety signals to define emerging drug safety profiles of all products and drive patient risk management. Delivers high-quality product safety data and analysis to internal and external customers throughout the product life cycle.

 

Education

• Advanced life sciences degree, preferably medical doctor, or equivalent through experience

Experience

• Minimum of 3-5 years of experience in a (global) healthcare organization, especially in Clinical Development and/or Medical Affairs and/or Pharmacovigilance
• Preferably in-depth experience in drug development process across different stages, especially clinical development and clinical operations
• Experience in development and authorship of complex PV documents
• Experience of leading and contributing to teams across cultures and geographies (if applicable)
• Experience of working across and building effective working relationships between functions

Skills & Competencies

• Strong organizational and process management skills
• Strong financial reporting experience and skills and understanding of business systems
• Demonstrated project management capability
• Highly effective communicator with strong influencing ability and communication skills
• Demonstrated ability to function effectively and successfully in a complex global and multicultural environment
• Ability to take personal responsibility and accountability
• Organized, able to multi-task effectively
• Knowledge in Pharmacovigilance relevant regulations

Languages

• Fluency in English (written and verbal communication skills)

Personal Attributes

• Collaborative, team-oriented, flexible