Key Responsibilities:
- Review and process safety events (pre-marketing, post-marketing, medical device, and drug) and other medically related information according to assigned tasks and project-specific procedures.
- Perform reviews of abstracts and full articles to identify safety information from literature sources for both pre and post-marketed products.
- Generate data listings from the safety database, ensuring accuracy of the data.
- Complete adverse event follow-up in writing and/or by phone as required for each client.
- Provide input and review relevant safety tracking systems for accuracy and quality, and assist with maintaining project files.
- Perform safety reviews of clinical and diagnostic data as part of case processing.
- Develop and maintain the Safety Management Plan, ensuring consistency within the project.
- Support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
- Liaise with investigational sites, reporters, and/or Sponsors regarding safety issues.
- Assist with identifying out-of-scope activities in conjunction with the Pharmacovigilance Project lead.
- Support audits and inspections as required for the assigned projects.
- Perform other activities as identified and requested by management, including responding to medical information inquiries related to adverse events and product complaints.
Benefits:
ICON offers a competitive salary package, annual bonuses based on performance goals, and a comprehensive range of health-related benefits for employees and their families. We also provide competitive retirement plans and related benefits such as life assurance. Beyond these, you will benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
