Pharmacovigilance Specialist, Case Processing

About the role

ProPharma, a consulting firm supporting biotech, medical device and pharmaceutical companies with regulatory, clinical research, quality, pharmacovigilance and R&D services, is hiring a Pharmacovigilance Specialist, Case Processing. The role covers the daily handling of adverse event cases from clinical trials and post-marketing.

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 of training materials and training delivery
• Flag concerns and discrepancies in ICSRs to the Principal PV Specialist, Case Processing and/or Manager, Case Processing
• Keep up to date with 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
• Preferred: advanced degree, RN, RPh, PharmD or equivalent
• Two years of related work experience

Required skills

• Basic knowledge of pharmacovigilance
• MedDRA coding
• Strong verbal, written and interpersonal communication skills
• High accuracy and attention to detail
• Able to work independently and in a multi-disciplinary team, with good organization and prioritization