About the Role
- Safety Event Review and Processing: Review and process safety events (pre-marketing, post-marketing, medical device, and drug) and/or other medically related information per assigned tasks and project-specific procedures.
- Literature Review: Perform review of abstracts and full articles to identify safety information from literature sources for both pre and post marketed products.
- Data Listing Generation: Generate data listings from the safety database and assume responsibility for accuracy of the data.
- Adverse Event Follow-Up: Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
- Safety Tracking System Review: Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
- Clinical and Diagnostic Data Review: Perform safety review of clinical and diagnostic data as part of case processing.
- Safety Management Plan Development: Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
- Post-Marketing Safety Activities: Support creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
- Qualified Person Support: Support Qualified Person for Pharmacovigilance as required.
- Stakeholder Liaison: Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
- Interdepartmental Collaboration: Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate.
- Scope Activity Identification: Assist with identifying out-of-scope activities in conjunction with the Pharmacovigilance Project lead (as applicable).
- Meeting Participation: Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings.
- Aggregated Safety Report Support: Support the generation of Aggregated Safety Reports (e.g., Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
- Interim Data Analysis Support: Support interim data analysis for DMC reviews.
- Safety Database Maintenance: Effectively maintain the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
- SAE/AE Reconciliation Support: Support creation of the SAE/AE reconciliation plan and support SAE reconciliation in accordance with this plan and other project-specific guidelines.
- Signal Detection and Risk Management Support: Support Safety Scientist in signal detection and risk management activities.
- Plan Consistency Assurance: Assure consistency of plans with client contract and identify out-of-scope activities promptly and accurately.
- Issue Resolution: Propose solutions for procedural and technical issues.
- Audit and Inspection Support: Support audits and inspections as required for the assigned projects.
- Other Activities: Perform other activities as identified and requested by management, including but not limited to responding and processing medical information inquiries, including inquiries related to adverse events and product complaints for Clients’ products, as per their agreement with ICON.
