Drug Safety Executive (ICSR Case Processing)
Drug Safety Executive (ICSR Case Processing)
Fidelity Health Services
Job description
Fidelity Health Services is hiring a Drug Safety Executive for ICSR case processing in Ahmedabad, offering a great career opportunity for B.Pharm and M.Pharm graduates with 1 to 2 years of pharmacovigilance experience.
Company Description
Fidelity Health Services is a global pharmacovigilance company started in 2015, with offices in Toronto, London, Mumbai, and Pune. It provides drug safety and regulatory support to pharma and biopharma clients around the world. It was the first CRO in India to offer drug safety services on a functional service provider model. Its work is built on patient safety and quality.
Job Summary
This is a full-time, on-site role in Ahmedabad for a Drug Safety Executive in ICSR case processing. The person will enter, check, and manage safety cases in the Oracle Argus database. The role also covers quality checks, literature case processing, and case follow-up. Candidates need 1 to 2 years of case processing experience, and immediate joiners are preferred.
Key Responsibilities
Check for duplicate cases, book in cases, and manage them in the Oracle Argus Safety database.
Check data against source documents and set procedures.
Enter and quality-check individual case safety reports.
Process regulatory, spontaneous, vendor, and literature cases.
Fix case data found during signal reports, health hazard assessment reports, routine signal reviews, post-process quality checks, and FAERS reviews.
Follow up on safety cases and create action items in Argus.
Educational Qualification
A BAMS, BHMS, B.Pharm, or M.Pharm degree is needed.
Candidates should have 1 to 2 years of experience in case processing.
Skills Required
Knowledge of pharmacovigilance case processing and ICSR work is essential.
Familiarity with safety databases such as Oracle Argus, ArisG, or Veeva is required.
Understanding of database management and documentation practices is important.
Knowledge of pharmacovigilance rules, including FDA, EMA, and MHRA requirements, is necessary.
Analytical thinking, problem-solving, and decision-making skills are needed.
Clear communication and teamwork with departments are vital.
Salary Structure
The average annual salary for a Drug Safety Executive at Fidelity Health Services in Ahmedabad ranges from ₹4 Lakhs to ₹6 Lakhs per year.
Career Development
This role builds strong skills in ICSR case processing within a global pharmacovigilance company. It can help you grow into a senior drug safety executive, safety scientist, or wider pharmacovigilance roles over time.
How to Apply
Visit our job portal and search for the Drug Safety Executive role at Fidelity Health Services in Ahmedabad.
Interested candidates should send their updated resume to: hrrecruitment@fidelityhs.com
Education
Bachelor's Degree
Key Skills
Market insights & trends
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