Understanding of global regulatory requirements for pharmacovigilance
Familiarity with clinical development processes
Case processing experience
Attention to detail
Competence in lifecycle safety systems and medical coding (LSMV is a plus)
Strong written and verbal communication skills
Comprehensive knowledge on MS Office applications
Description Supports the safety surveillance process for the client products by performing daily manual report review and follow up activities with patients and HCPs of individual case safety reports.
Purpose To support the safety surveillance process for the client products by performing follow up activities with patients and HCPs of individual case safety reports.
Ensure vendor compliance with approved processes and training requirements.
Oversee case quality of US ICSRs (CT and PM) including analysis and reporting of trends in quality measures.
Point of accountability for managing one or more key vendor relationships for ICSR processing.
Case processing point of contact for case related activities with assigned business partners.
Case processing point of contact for audit related activities related to case processing.
Accountable for measuring quality against contractual safety agreements.
Accountable FDA point of contact for ICSR reporting.
Submission of all individual safety reports to FDA, EMA and Business Partners.
Job Summary
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.
Key Activities Supports the safety surveillance process for the client products by performing daily manual report review and follow up activities with patients and HCPs of individual case safety reports.
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.
Case review / QC.
Escalation of case level quality issues.
Perform daily manual report review.
Knowledge and Skills
Understanding of global regulatory requirements for pharmacovigilance.
Familiarity with clinical development processes.
Case processing experience.
Attention to detail.
Competence in life cycle safety systems and medical coding.
Comprehensive English writing skills.
Excellent phone conversation skills.
Comprehensive knowledge on MS Office applications.
Key Relationships
Case Management vendors
GQM/BPO
SOPS
MSRT
LSOs
Business Partners
Education & Experience (Basic)
Bachelor's degree and 2 years of directly related experience OR
Associate's degree and 6 years of directly related experience
Soft Skills
Ability to be a self starter and train remotely
Able to work sufficiently remotely
Day to Day Responsibilities Supports the safety surveillance process for the client products by performing daily manual report review and follow up activities with patients and HCPs of individual case safety reports.
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.
Case review / QC.
Escalation of case level quality issues.
Perform daily manual report review.
Employee Value Proposition
Career growth
Opportunity
Industry experience
Networking
Possible Extension
Yes
Red Flags
Over qualified (basic position, 10+ years experience would be way overqualified)
Job hopping
Interview Process
Video conference
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $52.00/hr - $60.00/hr.
