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Aggregate Report

Pharmazone
Pharmazone
2-3 years
₹ 3L - ₹ 4L (Per Year)
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Aggregate Report – Junior Position

Location: Ahmedabad
Company: Pharmazone
Employment Type: Full-Time
Experience: 2 to 3 years
Salary: ₹3L - ₹4L per year
Posted on: November 21, 2024

Key Responsibilities:

  • Authoring of Aggregate Reports, including PSURs/PBRERs, PADERs/Annual Reports/ACO/DSUR, for submission to local and other health authorities.
  • Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
  • Authoring of Signal Management Reports.
  • Performing literature search and validity checks for aggregate reports.
  • Reconciliation of relevant process trackers.
  • Extraction and validation of data, including RSI, sales, previous reports, RMP, and signals.
  • Generation of Line Listings (LL) from the safety database.
  • Providing reliable support for high-priority ad-hoc activities.
  • Ensuring all reports are drafted within the allocated timelines.

Required Skills:

  • PSUR
  • PABER
  • Aggregate Report
  • RMPs
  • PADERs
  • DSUR