Drug Safety Specialist , NY

Job Overview

We are seeking a detail‑oriented and dedicated Drug Safety Specialist to join our team. In this role, you will play a key part in monitoring and assessing the safety of our products, ensuring compliance with global pharmacovigilance regulations and contributing to the safety and well‑being of patients worldwide. You will work closely with cross‑functional teams to ensure that all safety information is accurately reported and managed, helping to uphold the highest standards of drug safety.

• Monitor and evaluate the safety profiles of our products, ensuring compliance with global pharmacovigilance regulations and internal policies.
• Conduct thorough review and analysis of adverse event reports, medical literature, and safety data to identify any potential safety concerns.
• Collaborate with cross‑functional teams to facilitate timely and accurate reporting of adverse events to regulatory authorities.
• Develop, implement, and maintain processes and standard operating procedures to ensure adherence to pharmacovigilance guidelines and regulations.
• Provide guidance and support to internal teams on safety requirements, pharmacovigilance processes, and best practices.
• Serve as a point of contact for external partners, including CROs and regulatory agencies, regarding drug safety issues and concerns.
• Participate in the development and maintenance of risk management plans and safety‑related documents for our products.
• Conduct safety assessments, signal detection, and risk‑benefit analysis to identify potential safety signals and ensure effective risk management.
• Communicate relevant safety information to healthcare professionals, patients, and regulatory authorities as necessary.
• Stay up‑to‑date with changes in pharmacovigilance regulations, guidelines, and industry trends, and implement any necessary updates to processes.
• Participate in audits and inspections related to drug safety activities, ensuring compliance with all applicable standards.
• Train and mentor new members of the drug safety team, providing support and sharing expertise as needed.
• Engage in cross‑functional projects and initiatives aimed at improving and optimizing drug safety processes.
• Maintain accurate and complete documentation of all drug safety activities in compliance with regulatory and company standards.

• Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
• 2+ years of experience in drug safety, pharmacovigilance, or a related area within the pharmaceutical or biotech industry.
• Strong understanding of global pharmacovigilance regulations and guidelines.
• Experience in safety data review, adverse event analysis, and signal detection.
• Excellent communication and interpersonal skills, with the ability to work effectively across teams and with external partners.
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Strong analytical skills, attention to detail, and the ability to interpret and communicate complex safety data.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with safety databases or pharmacovigilance systems.