Senior Safety Project Lead

IQVIA•Mississauga, ON

22d•CA$80,000 - CA$106,600•Remote

About The Position

Responsible for management and service delivery excellence for assigned projects, covering single or multiple Lifecycle Safety functions (clinical trial and / or post-market). Provide leadership and accountability for customer-facing activities and oversight of operational service delivery, working cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers, aligned by accounts. Collaborate with global management team and integrated partners to develop and implement strategic initiatives/solutions to expand business, partnership, strengthen overall relationship and ensure global consistency.

Requirements

Bachelor's Degree Health science or other directly related field
2-3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience Req
Knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, IQVIA Standard Operating Procedures.
Strong prioritization (critical timelines), planning and organizational skills.
Effective verbal and written communication skills including ability to work and lead teleconferences.
Independently work on multiple projects and manage competing priorities.
Possesses knowledge of business acumen and financial analytical skills, tactical planning, and budgeting.
Ability to establish and maintain effective working relationships with coworkers, managers and customers.

Responsibilities

Manage customer interface and communication for assigned projects. Represent Lifecycle Safety on projects and serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams.
Manage customer deliverables for assigned projects and bring continuity to project design and delivery through customer delivery. Tactical, day-to-day customer-facing leadership at project level. Responsibilities include project planning (timelines, deliverables), defining project/scope management, quality management and project financial management.
Manage finances for assigned projects. Responsible for updating financial systems. Work closely with manager on revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.
Support start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage.
Attend meetings with internal (IQVIA cross functional project team members) and external (Customers and/or oversight group members) stakeholders. Provides project status updates, defines processes, project planning/strategy.
Contributes during client and internal audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans.
Work closely with Lifecycle Safety management to address problem areas and customer needs.