COD Research Hiring Sr. Medical Safety Associates (Aggregate Report) – BDS, Pharma/Lifescience

COD Research Hiring Sr. Medical Safety Associates (Aggregate Report)  Pharmacovigilance

Are you an experienced professional in medical safety reports seeking a challenging opportunity? COD Research is currently hiring Sr. Medical Safety Associates to join their team in Ahmedabad. This role is ideal for candidates with a BDS degree or a Bachelor’s in Pharma/Lifescience, combined with 4-6 years of relevant experience. Read on to learn more about this exciting career opportunity.

About COD Research

COD Research is a distinguished organization specializing in Pharmacovigilance and Clinical Research support for pharmaceutical, biotech, medical device, and vaccine companies worldwide. With offices in India (Ahmedabad) and the USA (New Jersey), COD Research is committed to designing therapies for the future.

Position Overview

Sr. Medical Safety Associates (Aggregate Report)

As a Sr. Medical Safety Associate at COD Research, you will be responsible for drafting and quality reviewing safety reports such as PADER, PBRER, PSUR, and others. Your role will include preparing and tracking Aggregate report schedules, understanding country-specific regulatory templates (US, EU, ROW), and ensuring compliance with regulatory requirements for safety reports.

Key Responsibilities

• Drafting and quality reviewing safety reports (PADER, PBRER, PSUR, etc.)
• Preparation and tracking of Aggregate report schedules
• Familiarity with US, EU, and ROW regulatory templates
• Handling regulatory queries related to safety reports
• Preparation of responses to regulatory queries
• Ensuring compliance with safety report regulatory requirements

Qualifications and Experience

• BDS degree or Bachelor’s in Pharma/Lifescience
• 4-6 years of experience in medical safety report drafting and quality review
• Strong understanding of regulatory requirements for safety reports

Work Location

This position is based in Ahmedabad and requires on-site presence.

About COD Research

COD Research is dedicated to supporting global pharmaceutical, biotech, medical device, and vaccine companies in their Pharmacovigilance and Clinical Research endeavors. Our team in Ahmedabad plays a crucial role in ensuring regulatory compliance and patient safety across various therapeutic areas.

Application Process

Interested candidates who meet the qualifications are encouraged to apply by sending their CV to career@cod-research.com