01Overview
This role will 100% remote
MD, Pharm D and PhD degree will not work
Not looking for scientific degree or engineering degree
Associates degree will also work
Looking for business degree
Masters degree, Nursing degree or pharmacy degree is overqualified (Scientific or engineering degree will not work)
Work as per CST hours (8:00 AM -5:00 PM CST)
Looking for a candidate who can work on the quality review of the reconciliation activity which is done with outsourcing vendor (India, manila, Budapest)
Intake activities (adverse event, product quality)
Some one who can do vendor oversight, Pharmacovigilance activity with ICSR, onboarding/offboarding for the vendor and other activities like reports on daily basis, ICSR follow up query process
Work with MS word, outlook & excel
Quick learner
Position is more of a support role for PV team
1 year of pharmacovigilance exp needed
Managing vendor oversight activity
Pharmacist or Nursing degree candidates will not work for this role
2-3 yrs Pharmacovigilance exp will also work
Not looking for clinical exp as this team only does post marketing work (This role is for non medical)
ICSR follow up query process
Veeva vault exp (case processing and adverse event activity)
Supporting post marketing products
Exp in product quality
Able to work in fast pace environment
Power BI exp is nice to have
Technical skills
Excel, PowerPoint skills
Power BI or Power automate skills
Job Description:
Accurate and timely registration of adverse event and product quality report from initial receipt to data entry within required timeframes.
Performing Quality Review of external providers reconciliation tasks for Clinical and Post-marketing (Medical Information, Product Complaints and third-party vendor ) cases.
Clearly and succinctly communicates information to customers verbally and in writing.
Demonstrates a high level of customer service to both internal and external customers.
Utilizes judgment skills to identify issues that impact the workflow.
Uses rigorous logic and methods to solve difficult problems with effective solutions.
Identifies gaps and areas that need improvement and communicates and/or implements recommendations/changes.
Performing tasks outside ones own area of responsibility to help with departmental needs
Effectively prioritizes and manages own time to complete assigned tasks.
Experience/Skills:
6 months to 1 year of similar work experience.
Excellent computer and keyboarding skills including Excel, PowerPoint, Word and Outlook (or equivalent email system).
Prior experience and familiarity with computer databases.
Superior attention to detail, quality, accuracy and timelines.
Strong time management and prioritization skills; ability to multi-task.
Strong adaptability to switching tasks to meet business needs.
Strong customer service skills.
Ability to work independently with minimal supervision as well the ability to work collaboratively and effectively within a team.
Fast learner of technical and process skills/knowledge.
Effective verbal and written skills.
Medical terminology knowledge preferred.
Prior experience in a regulatory/medical setting preferred.
Candidates must posses 3 to 5 years of experience or application/environment specific knowledge to perform tasks where large quantities of information, data or documents need to be maintained or manipulated in a structured database, filing system or associated reporting/holding format.
Job Type: Contract
Compensation: $25.00 - $26.00 per hour
Expected hours: 40 per week
Benefits:
Health insurance
Education:
Associate (Preferred)
Experience:
Pharmacovigilance: 2 years (Preferred)
Veeva: 2 years (Preferred)
Vendor Oversight: 2 years (Preferred)
ICSR: 2 years (Preferred)
Case Processing: 2 years (Preferred)
Power BI: 2 years (Preferred)
Ability to Commute:
Remote (Preferred)
Work Location: Remote
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Company : Systems Ally
Salary : Work from home
