Drug Safety Project Manager

Recognize, exemplify and adhere to ICON's values which center around exceeding expectations, excellence in execution and enhancing relationships and demonstrate our commitment to People, Clients and Performance. (SR – ICONs values have changes so have updated. Not sure whether we still need to refer to People, Clients and Performance) As an member of staff, the employee is expected to demonstrate the ICON behavioural competencies:Energy & Passion - A willingness and enthusiasm for work, take initiative, see change as an exciting opportunity. Delivers Excellence - Passion to deliver outstanding results and exceed customer expectations. Focused on excellence and quality. Integrity & Honesty - Truthful, dependable and reliable, admit mistakes, puts team ahead of self, expresses concerns and issues openly. Insight & Solutions - Acts before being required to by events to improve performance, avoid/resolve problems and/or find a better way, seeks better and more efficient ways of doing things. Understands outcomes, processes and one’s role in them, solves root issues and improves outcomes. As a Coordinator, the employee is expected to recognize the importance of and create a culture of process improvement, with a focus on streamlining ICON our processes thereby adding value to our the business and meeting client needs. Travel (approximately 10%) domestic and/or international. Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes. Provide oversight and/or review and process safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures 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 Generation, review and maintenance of project specific procedures Act as Pharmacovigilance lead for global projects and programs Act as project manager for some drug safety projects, liaising with sponsor, and management of timelines and budgets, as appropriate Coordinate functional safety activities in support of project manager on mid-size and large stand alone projects Coordinate and lead project teams as assigned Support development creation of post-marketing safety activities, such as PSMF, RMP and PBRER Support QPPV as required Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety-related project issues. Support development of clinical trial activities, such as DSURs, 6-monthly line listings, etc, by liaising with other ICON departments and/or other Sponsor vendors Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate, such as safety systems support for line listings or other requests from Argus or other safety database managed by ICON Actively identify out of scope activities and process efficiency/improvement needs Review assigned contracts and coordinate contract amendments/change orders as required Coordinate project team and Sponsor meetings (including Investigator meetings) and teleconferences as required Train/mentor Sr. Drug Safety Associate (and other team members) below) staff Coordination of interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities) Provide in-depth technical expertise Develop, maintain, and document workflow processes and liaise with external departments, as needed Completion of weekly and monthly project status reports including quality review findings and metrics, as required Develop and conduct safety presentation for start-up meetings, Investigator meetings and other meetings Assist with creation, coordination, and/or delivery of training to PVSS staff Participate in hiring process for new staff as requested Escalation of appropriate issues to manager Perform other activities as identified and requested by management Coordinate and present at meetings as required, such as client Kick-off meetings Ability to make decisions within the DS Coordinator’s scope of knowledge of regulations, ICON processes, and Sponsor processes, and communicate to colleagues