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Pharmacovigilance Operations Mgr
Location:
Abee
Description:
REMOTE - Sit anywhere in the US BILL RATE RANGE FOR THIS ROLE IS to (SUPPLIERS, YOU CANNOT SUBMIT ABOVE ) Day to Day Responsibilities: Supports the safety surveillance process for products by performing daily manual report review, acquisition activities, retrospective QC activities, reconciliation, follow up activities with patients and HCPs of individual case safety reports and support audits and inspections activities. Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements. Provide vendors with resources and training to perform their role. Support the analysis and communication of case QC results. Lead development and delivery of training materials for case management conventions. Support reviews of contract wording for case related data exchange. Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange Case review / QC. Escalation of case level quality issues. Support convention-related training delivery. Supporting the reporting of Adverse Event Case Reports to FDA/EMA/Business Partners within time frames determined by regulations and contracts. Perform daily manual report review. Perform QC and FU activities Support analysis of QC trends, audits and inspection queries Support acquisition and reconciliation activities support generating, communicating, and archiving of reports of QC findings level 5 - Doctorate degree OR Master's degree and 3 years of experience OR Bachelor's degree and 5 years of experience OR Associate's degree and 10 years of experience OR High school diploma / GED and 12 years of experience Knowledge and Skills - Understanding of global regulatory requirements for pharmacovigilance. Familiarity with clinical development processes. Case processing experience. Attention to detail. Competence in Argus safety systems and medical coding. Comprehensive English writing skills. Excellent phone conversations. Visit ListedBuy for more information.
Company:
Aequor
Posted:
December 15 2023 on ListedBuy
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More About this Listing: Pharmacovigilance Operations Mgr
Pharmacovigilance Operations Mgr is a Executive Manager Job at Aequor located in United States. Find other listings like Pharmacovigilance Operations Mgr by searching Oodle for Executive Manager Jobs.
Pharmacovigilance Operations Mgr is a Executive Manager Job at Aequor located in United States. Find other listings like Pharmacovigilance Operations Mgr by searching Oodle for Executive Manager Jobs.