Aggregate Safety Reporting Lead -REMOTE
- 1234, Cambridge, Massachusetts, United States
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
Please rush your resumes at [email protected] or feel free to reach me at 781-951-3820
• 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.
All your information will be kept confidential according to EEO guidelines.