The Senior Drug Associate (DSA) will, under the direction of the Director, provide oversight, training, and mentoring support to the Drug Safety Associates (employee and contractor staff) related to data entry and case processing. Assists in the development of safety surveillance processes and writing corresponding SOPs.
• Triages assigned adverse event reports using medical and regulatory expertise. Enters and maintains the events in the electronic drug safety database.
• Performs weekly reconciliation of adverse event and product complaint reports with Quality Assurance and Medical Information departments respectively. Maintains verification of reconciliation and email correspondence in Drug Safety shared drive.
• Using medical / pharmacological expertise to assist with data review, literature review and signal detection processes.
• Bachelor’s degree in in a relevant scientific or mathematics field or health related degree (RN, PharmD) or the equivalent in work experience in the drug safety arena is required.
• Minimum 5 years pharmaceutical experience in a Drug Safety/Pharmacovigilance unit.
• Prior experience with Drug Safety database entry and narrative writing.
• Demonstrate knowledge of applicable clinical trial regulations.
• Proven ability to evaluate clinical data.
• Excellent interpersonal, oral and written communication skills.
• Demonstrated understanding of the assessment and processing of safety reports.
• Working knowledge of pharmaceutical development process.
• Extensive knowledge of regulatory reporting obligations in both US and ROW.
• Collect, document and evaluate adverse event information from Healthcare professionals using medical knowledge, experience, and communication skills.
• Generate medical narratives derived from the collection of adverse event information and verify medical coding in the safety database system.