Aggregate Report Pharmacovigilance

8+ years

Not Disclosed

Ahmedabad

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 - Pharmacovigilance

Company: Lambda Therapeutic Research
Location: Ahmedabad (Work from Office, 6 days a week)
Experience: 8+ years in Aggregate Reporting
Qualification: M. Pharm / B. Pharm / Science Background

Overview:
We are seeking an experienced professional in Pharmacovigilance to join our team as an Aggregate Report Specialist. The role involves preparation and review of various aggregate safety reports, including PSURs, PADERs, and Annual Summary Reports, in compliance with applicable guidelines. The ideal candidate will have extensive experience in pharmacovigilance and safety data analysis.

Key Responsibilities:

Report Preparation & Review:
- Preparation and review of full PSURs (PBRER format), PADERs, Addendum to Clinical Overview Summary Report, and Annual Summary Reports as per GVP and ICH guidelines.
Risk Evaluation & Safety Data Analysis:
- Analyze safety data from line listings generated from the pharmacovigilance database for signal detection and risk evaluation.
Safety Literature & Data Review:
- Review published literature for new significant safety information and assess safety data from clinical and non-clinical studies, including safety variations.
Pharmacovigilance Expertise:
- Ensure pharmacovigilance activities are conducted in accordance with company SOPs, GVP guidelines for EU, Non-EU, and other RoW countries, and applicable regulations.
- Awareness of MedDRA coding and terminology.
Support to Pharmacovigilance Team:
- Provide support to other members of the pharmacovigilance team as required.
Client & Colleague Interaction:
- Provide pharmacovigilance advice and guidance to both internal colleagues and external clients.
SOP Development:
- Assist in the development and improvement of standard operating procedures for pharmacovigilance processes.
Other Duties:
- Undertake other tasks as assigned by the line manager to meet the business needs.

Desired Skills & Qualifications:

In-depth understanding of pharmacovigilance principles, GVP, and regulatory requirements.
Proficiency in aggregate report preparation, safety data analysis, and risk evaluation.
Strong knowledge of MedDRA coding and terminologies.
Excellent communication and interpersonal skills to interact effectively with teams and clients.

How to Apply:
Interested candidates can share their resumes to saurabhkharya@lambda-cro.com with the subject line: "Application for Aggregate Report".

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Aggregate Report Pharmacovigilance

Job Description

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