.Pharmacovigilance Associates/Senior Associates (Hybrid mode)ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team.Responsibilities: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.Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.Generate data listings from the safety database and assume responsibility for accuracy of the data.Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.Perform safety review of clinical and diagnostic data as part of case processing.Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER.Support Qualified Person for Pharmacovigilance as required.Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate.Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable).Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings.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.Support interim data analysis for DMC reviews.Effectively maintain the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.Support creation of the SAE/AE reconciliation plan and support SAE reconciliation in accordance with this plan and other project specific guidelines.Support Safety Scientist in signal detection and risk management activities.Assure consistency of plans with client contract and identify out of scope activities promptly and accurately.Propose solutions for procedural and technical issues.Support audits and inspections as required for the assigned projects