Senior Pharmacovigilance Specialist

About the Role

Our client is seeking a highly skilled and motivated Senior Pharmacovigilance Specialist to join their globally distributed team, operating remotely. This role is vital for ensuring the safety of patients by monitoring, collecting, assessing, and reporting adverse events associated with pharmaceutical products. You will play a key role in maintaining the company's safety database, performing case processing, and contributing to safety reporting obligations to regulatory authorities worldwide.

This is an excellent opportunity for an experienced pharmacovigilance professional to contribute to patient safety on a global scale, working from home in a role that requires utmost dedication to accuracy and compliance.

• Process and evaluate adverse event reports from various sources, ensuring accurate and timely data entry into the safety database.
• Perform case assessment, including causality determination and seriousness evaluation.
• Prepare and submit regulatory safety reports (e.g., Periodic Safety Update Reports, DSURs) in accordance with global timelines.
• Contribute to the development and maintenance of pharmacovigilance SOPs and training materials.
• Collaborate with internal departments and external partners to manage safety information effectively.

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA).
• Experience with safety databases (e.g., Argus, ArisG) and case processing.
• Excellent attention to detail, analytical skills, and the ability to work independently in a remote setting.

• A competitive salary and remote work flexibility.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and opportunities for professional development.
• Retirement savings plan with company contributions.
• A critical role in ensuring global patient safety, contributing to a vital public health function.