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Pharmacovigilance Associate Jobs in Hyderabad - UNICON LABS

Pharmacovigilance Associate

UNICON LABS
experience-icon 0 Years
salary-icon Not disclosed
Expired

Posted: 16 Jul 18

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

Education B.Pharm, M.Pharm, BDS, MD, MBBS, MSc
Who can apply Freshers
Hiring Process Face to Face Interview, Telephonic Interview
Employment TypeFull Time
Job Id448890
Job Category Pharma
Locality Address
State Telangana
Country India

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.

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