Pharmacovigilance Specialist, Case Processing

About the role

ProPharma, a consulting firm supporting biotech, medical device and pharmaceutical companies since 25 years, is looking for a Pharmacovigilance Specialist, Case Processing. The role covers the daily handling of adverse event cases, from coding to follow-up and peer review.

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 the information to be collected
• Create and review case narratives
• Provide client notifications as required for case management
• Support the development and delivery of training materials
• Flag concerns and discrepancies about 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
• Basic knowledge of pharmacovigilance

Required skills

• MedDRA coding
• Strong verbal, written and interpersonal communication
• Accuracy, attention to detail and problem-solving
• Organization, prioritization and ability to multitask
• Able to work independently and in a multi-disciplinary team