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.Company Description
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. Essential Functions Include: Individual Case Safety Report Processing Client Interaction Qualified candidates must have: We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***Job Description
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