Job details
Salary from $40 an hour job type full-time contract number of hires for this role 1
Qualifications
Bachelor`s (preferred)
Research: 1 year (preferred)
Licensed pharmacist (preferred)
Us work authorization (preferred)
Full job description
The specialist will participate in the set-up and maintenance of adverse event workflow, and be accountable for the development of department policies and standard operating procedures.
Main duties for the case management specialist may be assigned to intake & submissions or global case processing.
Key intake & submissions team activities may include, but are not limited to: timely intake, reconciliation and submission of individual case safety reports (icsrs) to and from destinations including but not limited to global regulatory authorities, business partners, investigators, and ethics committees in compliance with applicable global regulations/reporting requirements and jazz pharmaceuticals standard operating procedures and guidelinesIn addition, may contribute to the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other jazz pharmaceutical business area needs related to ae intake or reporting.
Regulatory intelligence review for icsr intake & submission requirements, and reference tracking tool maintenance
Authoring and maintaining ae intake and icsr submissions processes and standards, including ae follow-up
Act as an expert resource for ae intake and icsr reporting requirements and system configuration requests associated with, but not limited to, :
Med affairs/commercial programs, product launches, rwe & mkt research programs, product withdrawal or license transfer, social media, business partner case exchange etc.
Perform or oversee serious icsr finalizations & submissions –
Input to icsr exchange timelines in business partner sdeas, maintain reference tracking tool, and initiate requests to ssm for configuration/update of associated system rules for business partner sdeas
Icsr reconciliations from all sources other than clinical
Ensure proactive quality of delivery by pv service providers and internal jazz staff for ae intake & submission activities
Operational vendor oversight – ae intake vendor(s)
Job types: full-time, contract
Pay: from $40.00 per hour
Schedule:
8 hour shift
Education:
Bachelor`s (preferred)
Experience:
Research: 1 year (preferred)
Icsr: 3 years (preferred)
Pharmacovigilance or drug safety: 5 years (preferred)
License/certification:
Licensed pharmacist (preferred)
Work location:
Fully remote
Work location: remote
