Aggregate Report, Pharmacovigilance Hiring at Lambda Therapeutic Research

Lambda Therapeutic Research is actively hiring experienced professionals for an Aggregate Report, Pharmacovigilance role in Ahmedabad. If you have a strong background in pharmacovigilance and are looking to advance your career in a leading clinical research organization, this opportunity could be the perfect fit for you.

Job Overview

Lambda Therapeutic Research is seeking qualified candidates with expertise in aggregate report preparation and pharmacovigilance activities. This role requires professionals with in-depth knowledge of PSURs, PBRERs, PADERs, and safety data analysis. The selected candidates will be responsible for ensuring compliance with pharmacovigilance guidelines and regulations while delivering high-quality reports.

Key Job Responsibilities

As part of the Aggregate Report, Pharmacovigilance team, you will be expected to:

• Preparation / Review of full PSURs (PBRER format), PADERs, Addendum to Clinical overview summary report, and Annual Summary Report as per GVP and / ICH guidelines
• To evaluate the effectiveness of implemented educational materials for additional risk minimization measures and additional PV activities
• Safety data analysis from line listing generated from Pharmacovigilance database for signal and risk evaluation
• Review of published literature for new significant safety information,
• Review of safety data reported from clinical/non-clinical studies and safety variations
• Awareness of MedDRA coding and its terminologies
• Through awareness of good pharmacovigilance guidelines for EU, Non-EU, and other and RoW countries
• To ensure pharmacovigilance activities are carried out in accordance with company SOPs and applicable regulations / guidelines.
• To provide support to other members of the pharmacovigilance team as required
• To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues
• Assist in the development of appropriate standard operating procedures
• Any other tasks as requested as by line manager to meet the business requirements.

Required Qualifications and Experience

To qualify for this role, the ideal candidate must meet the following criteria:

• Education: M. Pharm, B. Pharm, or a science background is required.
• Experience: At least 8 years of experience in aggregate reporting and pharmacovigilance activities. Experience in preparing PSURs, PBRERs, and handling safety data analysis is essential.
• Location: Ahmedabad (Work from office, 6 days working).

How to Apply for the Aggregate Report, Pharmacovigilance Role

If you meet the qualifications and are interested in applying for this exciting opportunity at Lambda Therapeutic Research, please send your resume to:

📧 Email: saurabhkharya@lambda-cro.com
Subject Line: Application for Aggregate Report