Job Description

Drug Safety Specialist (Boston, MA; Dallas, TX; ...)

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.

Key Responsibilities:

• 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.

Qualifications:

• 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.
• 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.

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