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- Review and Process Safety Events: Handle safety events (pre-marketing, post-marketing, medical device, and drug) and 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 Management: Generate data listings from the safety database and ensure the 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 Systems: Provide input and review relevant safety tracking systems for accuracy and quality, and assist with maintaining project files.
- Case Processing: Perform safety review of clinical and diagnostic data as part of case processing.
- Safety Management Plan: Develop and implement the Safety Management Plan, ensuring consistency within the project.
- Post-Marketing Safety Activities: Support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
- Liaison: Communicate with investigational sites, reporters, sponsors, ICON Medical Monitor, project managers, and other departments regarding safety issues.
- Out of Scope Activities: Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project Lead.
- Meetings: Attend project team and sponsor meetings and teleconferences, including presenting the safety process at kick-off and investigator meetings.
- Aggregated Safety Reports: Support the generation of Aggregated Safety Reports through data retrieval and other assigned tasks.
- Interim Data Analysis: Support interim data analysis for DMC reviews.
- Database Maintenance: Maintain the safety database and corresponding entry guidelines, ensuring data quality following established quality control processes.
- SAE/AE Reconciliation: Support the creation and execution of the SAE/AE reconciliation plan.
- Signal Detection and Risk Management: Assist Safety Scientists in signal detection and risk management activities.
- Audit and Inspection Support: Support audits and inspections for assigned projects.
- Medical Information Inquiries: Respond to and process medical information inquiries, including those related to adverse events and product complaints for clients’ products.
Application Instructions: Interested candidates can apply through the “Apply” button or shortlist the job. For inquiries, contact Archana Bakkiyarajan.
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