Pharmacovigilance Specialist - Drug Safety

About the Role

Our client is looking for a diligent and detail-oriented Pharmacovigilance Specialist to join their drug safety team. This role operates on a fully remote basis, contributing to the safety monitoring of pharmaceutical products across all markets. You will be responsible for the collection, assessment, and reporting of adverse event data, ensuring compliance with global regulatory requirements and company procedures. This position is crucial for safeguarding public health by maintaining the safety profile of our client's medicines, providing a critical function within the pharmaceutical safety framework, and enabling effective risk management strategies.

Key Responsibilities

• Collect, evaluate, and document adverse event reports from various sources (spontaneous, clinical trials, literature).
• Perform medical assessment of adverse event data and determine reporting obligations.
• Submit timely and accurate safety reports to regulatory authorities and ethics committees.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs).
• Participate in drug safety signal detection and risk management activities.
• Maintain pharmacovigilance databases and ensure data quality and integrity.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 2 years of experience in pharmacovigilance or drug safety.
• Good understanding of global pharmacovigilance regulations and reporting requirements (e.g., GVP, FDA).
• Experience with safety databases (e.g., Argus, ArisG) is a plus.
• Strong analytical skills and the ability to critically assess safety information.
• Excellent written and verbal communication skills for remote collaboration.

Benefits

• Fully remote working arrangement with flexible hours.
• Competitive annual salary and performance incentives.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and company holidays.
• Opportunities for professional development and training in pharmacovigilance.