The Medical Affairs Group at Azurity is hiring a highly motivated Drug Safety Associate to join the team. Reporting to the Director of Drug Safety, this individual will support Pharmacovigilance activities across the organization. The candidate will leverage existing industry knowledge, organizational and communication skills to support ongoing drug safety initiatives while maintaining compliance.
Key Responsibilities:
- Assist in maintaining compliance with Pharmacovigilance (PV) activities according to company policies, SOPs, and FDA regulations
- Aid in safety agreement editing, renewal tracking, and formatting
- Support the management and oversight of safety-related information
- Assist with individual case review and management, including company-sponsored clinical trials
- Manage the core drug safety email system
- Track and reconcile safety information between partners
- Ensure timely responses to partners by managing daily workflows and communications cross-functionally
- Oversee weekly and monthly safety reports
- Organize safety project management internal tools
- Review, organize, and author standard operating procedures
- Maintain electronic files to ensure audit readiness
- Review Expedited and Non-expedited safety reports and source documents for completeness and accuracy
- Contribute adverse event information for safety reports including PADERs, PSURs, and safety data for clinical reports
- Maintain pertinent workflows to improve report quality and submission
- Prepare and edit safety-related training materials
- Collaborate with other departments for timely report processing
- Maintain the integrity of confidential information
Qualifications and Education Requirements:
- Bachelor’s or master’s degree in life science or healthcare-related field OR equivalent combination of education and experience
- At least 3 years of experience reviewing individual case reports, aggregate reports, and literature for adverse event reporting
- Strong analytical ability to summarize case reports, studies, and specific topics
- Experience with literature databases and safety databases
- Excellent communication and organizational skills
- Problem-solving skills, especially with respect to enforcing safety rules and global procedures
- Fluent in English with excellent written/oral communication skills
- Proactive with the ability to meet timelines
- High degree of responsibility, accountability, and responsiveness
- Ability to develop cooperative working relationships with all levels of staff
- Conversant in medical terminology and MedDRA coding
- Proficiency in Adobe Acrobat and Microsoft Office (Word, Excel, PowerPoint)
- Capable of working in a team-oriented and rapidly changing environment
- Understanding of FDA Regulations
Physical & Mental Requirements:
- Ability to sit for long periods
- Frequently required to stand, walk, sit, talk, and hear
- Occasionally climb stairs and/or ride elevators
- Occasionally lift and/or move up to 25 pounds
- Manipulate a keyboard, operate a telephone, and hand-held devices
