Pharmacovigilance Associate Jobs in Hyderabad - UNICON LABS
Job Description
- Receive information on adverse
events, perform initial checks, search database to prevent duplicate entries,
create case file and initialize received drug safety reports in Oracle Argus safety
database.
- To perform initial triage of the
received safety notifications.
- To process Individual Case Safety Reports (ICSRs), including data entry into
the Oracle Argus safety database.
- To follow-up ICSRs with the reporter, generate follow up (FU) queries and send
FU requests
- To handle technical product complaints.
- To perform ICSR reconciliations with business partners.
- To review local literature screening search results, identifying ICSRs and
other safety-related findings.
- A narrative
detailing report received date, patient’s medical history, drug therapy
details, adverse event/diagnosis and related details, concomitant drug
details, lab data, action taken, outcome and causality assessment. In simple to
say prepare narratives summarizing the essential details of the case.
- Forwarding
or proofing the case to expedited reportability in ARGUS.
- Always
ensure to maintain internal case processing timelines.
- Locking non
serious/not suspected PMS in ARGUS.
- Processing
complete data entry for cases and forwarding to QC workflow.
- Ensure
scientific rigor through accurate, complete and consistent data entry of
adverse event reports from source documents with emphasis on timeliness
and quality.
- Evaluate
and finish processing of non-expeditable AE reports, including review
for completeness and accuracy.
- Use medical
dictionaries and business guidance to code medical history, drugs and adverse
event terms.
- Identify
clinically relevant information missing from case report and facilitate its
collection (inconsultation with medical staff as required) by preparing
follow-up request as needed.
- Alert
manager or team lead to potential safety signals based on incoming case
reports.
- Send monthly
compliance metrics to manager or team lead as directed.
Job Particulars
About Company
UNICON LABS Private Limited is incorporated in 2013. Unicon Labs have more than 4 years of experience in Staffing & Recruitment and also provide Corporate Training by well experienced trainers. We have high-quality infrastructure and facilitates for industry oriented better instruction. It creates confidence to the students to get success in their career. we have a team of passionate and dedicated professional trainers who are well experienced in their specialisation to teach our students as per the present industry standards to complete for their edge and success.
Corporate Training provided in Pharmacovigilance, SAS and Medical Coding with placement support.
We offer job oriented with 100% placement assistance Education & Training program in Pharmacovigilance and Clinical Research in Corporate Sector.
Training provided by skilled and experienced, competent & diligent Pharmacovigilance professional having 10 years experience in Sponsor and CRO.