ICON plc is a global leader in healthcare intelligence and clinical research, providing outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations. With a strong focus on patient safety and drug development, ICON plays a crucial role in advancing clinical research and ensuring regulatory compliance.
Job Description
As a Pharmacovigilance Associate at ICON plc, you will be responsible for drug safety monitoring, adverse event reporting, and risk assessment to ensure compliance with global pharmacovigilance regulations.
Key Responsibilities:
- Collecting and reviewing adverse event (AE) reports for accuracy and timely submission.
- Conducting signal detection and risk assessment to identify potential drug safety concerns.
- Collaborating with cross-functional teams (clinical research, regulatory affairs, and medical teams) on safety-related issues.
- Assisting in the preparation of Periodic Safety Update Reports (PSURs), DSURs, and regulatory submissions.
- Ensuring compliance with ICH-GCP, FDA, EMA, and other pharmacovigilance guidelines.
- Maintaining safety databases and supporting audits/inspections.
Candidate Profile
Education & Experience:
- Bachelor’s degree (B.Pharm, BSc in Life Sciences, Pharmacy, or related field).
- Advanced degree (M.Pharm, MSc, PharmD) preferred but not mandatory.
- Freshers or 1-2 years of experience in pharmacovigilance, drug safety, or clinical research.
- Knowledge of MedDRA, WHO-DD, and Argus/Safety Databases is a plus.
Skills Required:
- Strong analytical and data interpretation skills.
- Excellent communication and documentation abilities.
- Attention to detail for accurate case processing.
- Understanding of global pharmacovigilance regulations (GVP, ICH E2A-E2F).
Additional Information
- Location: Chennai
- Industry Type: Pharma / Healthcare / Clinical Research
- Functional Area: Drug Safety / Pharmacovigilance
- Employment Type: Full-time
- Last Date to Apply: 20th May 2025
Why Join ICON plc?
- Work with a global leader in clinical research.
- Career growth opportunities in pharmacovigilance and drug safety.
- Competitive salary and benefits.
- Exposure to cutting-edge drug safety technologies.
How to Apply?
Interested candidates can apply through the official ICON plc careers portal or submit their resumes to the provided contact details.