Job Summary
ICON plc, a global leader in clinical research and healthcare intelligence, is hiring a Safety Scientist for its offices in Bangalore, Chennai, and Trivandrum. This exciting opportunity offers professionals with experience in pharmacovigilance and drug safety the chance to advance their career in a dynamic and inclusive work environment. The role focuses on safety surveillance, regulatory submissions, and risk management activities essential for drug development and patient safety.
Key Responsibilities
Conduct safety surveillance for assigned projects, reviewing and interpreting safety data.
Collaborate with cross-functional teams ensuring participant safety and regulatory compliance.
Develop and implement safety management plans and risk minimization strategies.
Prepare safety documentation for regulatory submissions and responses.
Lead operational pharmacovigilance activities and client meetings.
Author and review aggregate safety reports, including literature search and analysis.
Manage signal detection, validation, and assessment reports.
Contribute to the development of risk management plans (RMP, dRMP, REMS).
Maintain Pharmacovigilance System Master Files (PSMF) and agreements.
Support audits, inspections, SOP development, and training initiatives.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or related field (advanced degree preferred).
Strong background in pharmacovigilance/drug safety within pharma or clinical research.
Knowledge of GVP, ICH-GCP, pharmacovigilance regulations, and guidelines.
Experience in safety surveillance, aggregate report generation, and risk management planning.
Proficiency in literature search, data review, and signal detection.
Excellent communication and analytical skills.
Ability to coordinate with cross-functional and global teams.
Detail-oriented with the ability to manage multiple projects simultaneously.
Perks & Benefits
Competitive salary package.
Annual performance bonuses.
Health insurance for employees and families.
Retirement planning and life assurance benefits.
Global Employee Assistance Programme (LifeWorks).
Optional benefits including childcare vouchers, gym discounts, travel subsidies, and health assessments.
Flexible leave entitlements and work-life balance initiatives.
Company Description
ICON plc is a world-renowned clinical research and healthcare intelligence organization committed to improving patient lives globally. With cutting-edge solutions in drug development and regulatory affairs, ICON partners with the top pharmaceutical and biotechnology companies worldwide.
Work Mode: Hybrid (Bangalore, Chennai, Trivandrum)
Call to Action
Are you ready to contribute to global healthcare innovations and drug safety? Apply now for the Safety Scientist position at ICON plc and advance your career in pharmacovigilance and clinical research.
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