Address
Form of workJob Description
Top 3 Must Have Skill Sets:
Knowledge and Skills -
PAY RATE : $37-$42/hr on W2
"This posting is for Contingent Worker, not an FTE"
- Acquisition experience
- Audits and inspection facing experience
- End to end case processing and safety database experience
- Supports the safety surveillance process for Amgen 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
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 skills.
- Comprehensive knowledge on MS Office applications.
PAY RATE : $37-$42/hr on W2
"This posting is for Contingent Worker, not an FTE"
