Senior Pharmacovigilance Associate

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements and timelines
• Perform ICSR follow-up, including SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review
• Perform clinical and partner reconciliation
• Handle personal data protection requirements
• Handle Product Quality Complaints and interact with Quality Assurance
• Interact with Medical Information
• Perform MedDRA and WHO coding
• Produce database outputs and reports, including data for monthly client reporting
• Manage workflow and resources
• Support pharmacovigilance processes related to ICSR management within PrimeVigilance and for clients
• Perform tasks assigned under SOPs to more junior positions
• Support the RA & PV Network Department as needed
• Act as LCPPV (Local Contact Person for Pharmacovigilance) for the specified country when assigned
• Act as PRLS (Person Responsible for Local Screening) for the designated language when assigned

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Minimum 1 year of work experience in pharmacovigilance
• Organization skills, including attention to detail and multitasking
• Management skills, including time and issue management
• English - advanced (spoken, written)
• Advanced literacy (MS Office)

• Remote work option
• Flexible work environment
• Growth opportunities
• Collaborative team environment
• Diverse and inclusive workplace
• Belonging-focused culture
• Work with global teams across Europe, North America, South America, Asia and Australia
• Opportunity to contribute to patient safety and pharmaceutical treatment
• Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting