Senior Pharmacovigilance Associate

PrimeVigilance

2d

About The Position

Performing activities in the scope of the ICSR management unit within the agreed extent and timeframe. This includes processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements and timelines. The role also involves ICSR follow-up, SAE/SUSAR management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review), reconciliation (clinical, partners), personal data protection, product quality complaint handling and interaction with Quality Assurance, Medical Information interaction, MedDRA and WHO coding, database outputs and reports, and workflow & resource management. Support of PV processes related to ICSR management within PrimeVigilance and also to clients is expected. More senior colleagues may perform tasks assigned to more junior positions. Additionally, the role involves supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager.

Requirements

• 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)

Responsibilities

• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHO coding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management
• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Supporting the RA & PV Network Department as needed
• Acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country
• Taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree