Labcorp Project Manager Drug Safety in Boston, Massachusetts
Provide leadership and management of assigned global projects and/or programs ensuring that communications and processes are harmonized.
Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget and escalate to upper management as needed; and provide necessary data to support Change Notification Forms and/or Change Orders.
Track and monitor changes to the project scope, project schedule, and project costs using appropriate verification techniques.
Define and manage internal resources and third parties/vendors at a study level, proving feedback to upper management as needed.
Maintenance of adverse event reporting requirements in all countries. Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
Work closely with the clinical operations and project management groups to ensure all DDSS&A activities are performed according to the regulatory and contractual requirements.
Provide oversight of the receipt and processing of all adverse event reports/ expedited safety reports coming from either spontaneously from any source or from a clinical trial for assigned projects. This might include, but is not limited to, executing routine quality review of AE reports ensuring that case processing and data quality meet global regulatory compliance needs.
Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
Responsible for preparation and review of Safety Management Plans (SMPs), Reconciliation Plans and other specific plans, as applicable.
Non - degree + 6 to 7 years safety experience
Associate degree +5 to 6 years safety experience
Associate degree RN +5 to 6 years safety experience
BS/BA +4 to 5 years safety experience
MS/MA +3 to 4 years relevant experience ** (2-3 years safety experience)
Pharma D +2 to 3 years relevant experience ** (1-2 years safety experience plus project management skills)
Compliance with client and global regulatory requirements
Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
Good knowledge of ICH guidelines
Good knowledge of medical and drug terminology
Work collaboratively with DDSS&A Management’s team
Good Verbal, written and presentation skills
Excellent communication and negotiation skills
Client facing experience
Leadership and demonstrated project management capabilities
Anticipate/identify problems and takes appropriate action to correct
Knowledge of Medical Device Reporting desirable
Knowledge of aggregate reporting
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance
Good keyboard skills, preferable with knowledge of MS office and Windows would be beneficial
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