Drug Safety Associate III

• Establishes and maintains departmental procedures; oversees training and continuous improvement.
• Support DSP in pharmacovigilance activities including: signal detection and tracking activities, literature surveillance, oversight of medical review performed by outsourced vendor
• Collaborate with DSP safety physicians with PV activities as assigned
• Writing safety analysis reports
• Oversight of medical review and aggregate report activities performed by outsourced vendors
• Support clinical project teams for investigational products; provide project teams providing expertise in PV activities
• Collaborate with Clinical Research and Development, medical Affairs, Regulatory Affairs
• Provide Leadership in the development, implementation, and maintenance of robust procedures for PV activities within the DSP department
• Participate on the Safety Evaluation Group with local and global drug safety colleagues to monitor and discuss safety signal evaluation topics
• Contribute to the writing and compilation of PADERs, Annual reports and PSURs/PBRER.
• Author and review department SOPs as needed.
• Participate in Regulatory Inspections, external audits and investigator meetings
• Drug safety representative on Purdue intradepartmental committee for review and approval of clinical trial protocol language and clinical study processes
• Acts as a Subject Matter Expert in PV regulatory inspections and internal/external audits.
• Collaborates with internal stakeholders and Purdue subsidiaries to establish and maintain the Corporate AE Policy.
• Collaborate with Drug Safety Operations and Drug Safety Systems as needed, to ensure appropriate metrics per SOP.

Requirements:

• Bachelor's degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
• Minimum 10 years of experience in a pharmaceutical/biopharmaceutical company
• Minimum 7 years of Drug Safety experience
• Up-to-date knowledge of US and international PV regulations and best practices
• Thinks globally and considers present and future impacts when making recommendations
• Experience with PV vendor and business partner oversight and contract/agreement management
• Strong negotiation and problem-solving skills
• Analytical skills and attention to detail
• Accountability – takes ownership of deliverables