Pharmacovigilance Specialist, Case Processing

About the role

ProPharma, a provider of regulatory, clinical research, quality, pharmacovigilance and R&D consulting services, is looking for a Pharmacovigilance Specialist, Case Processing. The role covers the daily handling of adverse event cases from clinical trials and post-marketing, with peer review and reporting to the Principal PV Specialist and Manager.

Key responsibilities

• Process adverse event cases daily (clinical trial and/or post-marketing), including coding with MedDRA and assessing seriousness and expectedness at event and case level
• Carry out case follow-up, identifying information to be collected
• Create and review case narratives
• Provide client notifications as required for case management
• Support the development of training materials and training delivery
• Flag concerns and discrepancies in ICSRs to the Principal PV Specialist, Case Processing and/or Manager, Case Processing
• Maintain up-to-date knowledge of global safety regulations for medicines
• Peer review cases for quality, consistency and accuracy as needed
• Other duties as assigned

Required profile

• Bachelor's degree in life sciences (advanced degree, RN, RPh or PharmD preferred)
• Two years of related work experience
• Strong verbal, written and interpersonal communication skills
• High accuracy and attention to detail, good organization and prioritization, able to multitask
• Able to work independently and in a multi-disciplinary team

Required skills

• Basic knowledge of pharmacovigilance
• MedDRA coding