Job Purpose  

Contributes to pharmacovigilance Process and Metrics activities supporting drafting of process steps, analyzing metrics data and supporting Process owners and Metrics analysts in routine tasks and/or other PS&PV initiatives.

Major Activities

• Monitor Pharmacovigilance Process Excellence mailbox(es) in scope of responsibilities, triage queries and respond or forward the query as appropriate.

• Contribute to the evaluation of PV regulations
• Develop and maintain training materials and communications for Novartis group and third party associates.
• Work in collaboration with the Compliance & Quality function to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements.
• Preparing draft reports / presentations on compliance metrics or PV process
• Support projects; assisting the lead to coordinate the team, completing tasks within the project and preparing documentation.

Key Performance Indicators 

Successful completion of assigned process & compliance tasks Quality and timeliness of deliverables

Ideal Background 

Education (minimum/desirable):

PharmD, M Pharma, MSc or degree in life sciences or equivalent.

Languages:            

Fluency in English. Knowledge of other languages desirable.     

Experience/Professional

requirement:     

• Minimum 0 to 3 years of experience in the pharmaceutical industry, particularly pharmacovigilance
• Experience of working with project teams in a matrix environment
• Good communication and presentation skills
• Good organizational skills