Roles and Responsibilities
Aggregate SafEty Reports:
- Support/lead end-to-end preparation of aggregate safety reports. Support coordination with other line functions including Regulatory Affairs team to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
- Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs.
- Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all Health Authority (HA) requirements
- Support in creating a strategy for data analysis and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs.
- Support in the development of safety document templates and Standard Operating Procedures pertaining to safety aggregate reports
- Contribute to global projects focusing on process & quality improvement initiatives. Contribute as subject matter expert during Health Authorities inspections/audits and contribute in development, implementation of appropriate Corrective and Preventative Actions (CAPA).
- Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans
- Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Group guidelines/SOPs
- Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution
- Attend internal and technical team meetings as required
- Assist management as needed with preparation of resourcing estimates for potential new medical writing projects
- Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner
Desired Candidate Profile
- Results and performance driven deliver results that meet or exceed expectations
- Sense of urgency responding to issues and opportunities in a timely manner
- Intellectual curiosity willing to suggest and try new ideas
- Positive and pro-active approach to business tasks
- Excellent interpersonal and communication skills
- A solutions provider with strong multi-tasking abilities
- Manage evolving deadlines effectively with regular feedback and updates
- Enthusiasm and Drive to take ownership and drive process initiatives