Pharmacovigilance Manager

Requirements to candidate 

• Significant pharmacovigilance experience more than 5 years is required across the product life cycle
• Significant experience in pharmacovigilance legislation and processes 
• Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry, post-graduate in business or sciences as a plus
• Fluent in both written and spoken English is a must; German is highly preferred (any further languages are an advantage)

 Major Responsibilities

 Planning and preparation of Aggregate reports (PSURs, ACO, RMPs) and QC

• Perform quarterly PSMF updates, provision of source data
• Preparation, monitoring and update of key activities plan to ensure effective capacities utilization and KPIs fulfillment (e.g. safety variations)
• Support Global PV operations, ensure filing and archiving of PV documents, and organize and participate PV meetings
• Ensure definition and maintenance of reference safety information based on product information of a defined marketing authorization
• Cooperate with PV and Medical regarding safety and labeling topics, compliance and inspection readiness 
• Provide risk assessment and prepare DL responses 
• Identify the need for new pharmacovigilance procedures and SOPs, and participates in development and implementation
• The employee will perform other tasks under the direction of the Manager within the agreed type of work.
• Participates in inspections and audits 
• Responsible for PV training compliance for CH & DE Acino staff including documentation 

EMPLOYMENT  freelance based.