ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Senior Clinical Pharmacovigilance Specialist will manage individual case safety reports (serious adverse events, adverse events of interest and reports of pregnancy) through intake, documentation and processing. Additionally, they will perform initial case-level assessment of expectedness; confirms seriousness; composes accurate and thorough medical narratives and generates site queries for missing or unclear information. The Senior Clinical Pharmacovigilance Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, SMPs, SOPs and applicable safety regulations. They will maintain distinctive quality and commitment as the operating philosophy in carrying out all processes, while continually seeking out ways to enhance customer service experience both internally and externally.
*Home Working flexibility
Essential Functions Include:
Individual Case Safety Report Processing
Qualified candidates must have:
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