Senior Pharmacovigilance Associate

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client requirements, and timelines
• Perform ICSR follow-up activities
• Manage SAEs/SUSARs, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review
• Perform clinical and partner reconciliation
• Handle personal data protection activities
• Handle Product Quality Complaints and interact with Quality Assurance
• Interact with Medical Information
• Perform MedDRA and WHO coding
• Prepare database outputs and reports, including monthly client reporting data
• Manage workflow and resources
• Support pharmacovigilance processes for PrimeVigilance and clients
• Perform tasks assigned to more junior positions as appropriate for a senior colleague
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

• 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
• Advanced spoken and written English
• Advanced literacy in MS Office

• Remote work option
• Flexible work environment
• Growth opportunities
• Supportive and collaborative team culture
• Belonging and inclusive workplace
• Opportunity to work on global pharmacovigilance projects
• Opportunity to help protect patients through meaningful work