Aggregate Safety Reporting Lead -REMOTE

  • 1234, Cambridge, Massachusetts, United States
  • Contract

Company Description

Infotree’s approach to every employee and customer is based around making a positive impact. We focus on over-servicing, continuous improvement and a high-quality culture.  We’re passionate about making successful matches for our employees and customers across the globe. Infotree prides itself in our proven track record and innovative culture with 100% focus on the employees and customers

Job Description

Please rush your resumes at [email protected] or feel free to reach me at 781-951-3820
ACCOUNTABILITIES: 
• Interacts and communicates effectively internally and cross-functionally in a highly matrix environment. 
• Responsible for the implementation and management of effective structure, procedures and tools to ensure aggregate report and other functional deliverables are completed with high quality 
• Responsible for strategic oversight of aggregate safety reports for investigational and marketed products 
• Collaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc) contributing to aggregate safety reports 
• Manages distribution of assignments and prioritization of tasks within the Pharmacovigilance operations aggregate reporting team 
• Manages resource planning and ensures adequate support from internal team and vendor team to deliver all scheduled safety reports. 
• Manages commitments with license partners to ensure both meet aggregate reporting requirements as per the PV Agreement between companies. 
• Provides strategic oversight of Vendor and manages both quality and compliance of assignments, including training and mentoring when appropriate 
• Oversee functional specifications of any data requirements for aggregate deliverables from the Global safety database and analytics team 
• Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance findings 
• Support continuous improvement/quality system initiatives 
• Assist in preparation and support of audits and inspections 
• Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports 
• Establishes and chairs document working groups comprised of authors and subject matter experts (SMEs) from the project or product teams, as necessary 
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: 
• Bachelors required. Degree in scientific/medical field or advanced degree preferred 
• Minimum 8 years pharmaceutical or health care related industry experience required; previous experience working in global environment preferred. 
• Minimum 5 years experience in Pharmacovigilance with experience in preparation and submission of periodic aggregate safety reports. 
• Minimum 3 years experience working with CROs, vendors, and relationship management preferred. 
• Excellent organization skills and ability to prioritize individual and team work loads 
• Expert knowledge of Global regulatory requirements 
• Experience in vendor management for outsourced activities 
• Ability to work in a dynamic environment and manage competing priorities 
• Understand safety data capture in clinical trials and post marketing settings 
• Good written and verbal communication skills 
• Ability to work under strict deadlines and changing priorities with minimal supervision 
• Excellent negotiation, conflict resolution, decision making, problem solving and critical thinking skills 
• Experience with and demonstrated success in working on cross-functional diverse teams required 
• Ability to interpret, analyze and clearly present scientific and technical data 
• Scientific / medical writing (including word processing and data presentation packages (i.e. Word, Excel) 
• Ability to thrive in a global matrix environment 
• Experience with aggregate analysis and writing PSUR's, PADER’s and DSUR. 
• Knowledge of case processing and aggregate reporting requirements. 
• Demonstrated proficiency with computer applications and understanding of safety data. 
• Knowledge of pharmaceutical business, including drug development and regulatory aspects. 
• Knowledge of US, EU and international regulatory/safety regulations and guidelines. 
• Fluency in oral and written English.
 

Additional Information

All your information will be kept confidential according to EEO guidelines.