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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Pharmacoepidemiology Coordinator


Reference:SCATAR-407617 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Pharmacologist, Pharmacovigilance, PhD, Scientist

Pharmacoepidemiology Coordinator
Our client, a global pharma organisation are currently recruiting for a Pharmacoepidemiology Coordinator to join a new team within the organisation on a permanent basis. As Pharmacoepidemiology Coordinator you will be responsible for providing operational support in the design and implementation of pharmacoepidemiology studies. You will also support the development and maintenance of consistent operational processes for completing this work and other related Pharmacoepidemiology work.

Responsibilities

  • Establish regular communication with key GPS, regulatory, business unit (BU) and affiliate personnel as appropriate for specific studies
  • Provide operational consultation resources, tools, and expertise as needed to support specific studies
  • Liaise between Pharmacoepidemiology scientists and Sourcing/Procurement/ Quality in the contracting of Pharmacoepidemiology studies to external vendors to ensure cross-functional communication and overall coordination in the development of RFPs, identification of TPOs, creation of resourcing requests, and advising on scope of work for determining quality assessment requirements
  • Assess operational feasibility for planned Pharmacoepidemiology studies, ensuring that privacy, local laws, affiliate requirements, logistical requirements and other operational elements are considered
  • Coordinate the development of communication plans for teams as needed
  • Influence complex business or technical issues in the management of resources necessary to ensure study success
  • Anticipate and resolve key technical and operational problems and coordinate change management for studies and deliverables; this will require tactical understanding of all Safety Quality System & Medical Quality System requirements applicable to the GPS Pharmacoepidemiology to ensure study execution is in compliance with all internal requirements.
  • Adapt plans and implement appropriate changes in response to rapidly changing requirements and environment
  • Coordinate and facilitate the functioning of Pharmacoepidemiology studies in collaboration with product specific Project Management, as required which would include tracking of study milestones
  • Monitor the implementation and execution of Pharmacoepidemiology studies in conjunction with the other groups within the organisation and execute interventions necessary to ensure attainment of milestones and deliverables; this would include applicable internal documentation of appropriate GPS oversight
  • Coordinate and/or facilitate team review meetings and after-action reviews- both internal as well as with regulatory agencies (in conjunction with regulatory scientists) to identify process issues and strengths
  • Drive solutions leading to consistency in tracking, documenting and communicating project metrics
  • Identify, communicate and manage the critical path and leading indicators of team progress and major milestones across multiple products
  • Influence resource prioritization decisions across portfolio as well as vendor selection decisions.
  • Work closely with Pharmacoepidemiology Senior Director and/or delegates to identify operational gaps & drive solutions departmentwide
  • Build relationships with internal cross-functional customers and external TPOs involved in implementation on Pharmacoepidemiology projects
Requirements
  • Bachelor's degree (or higher) in a science-related field 2. 5 years of experience with cross functional project management, drug development or a related field in the pharmaceutical industry
  • Experience in Pharmacovigilance and patient safety
  • Experience with implementation of observational studies
  • Proficiency in MS Project and Vision
  • Applied knowledge of project management tools and processes (e.g. management of integration of scope, time, cost, quality, human resources, communications, risk and procurement)
  • Proficiency with MS Word, Excel and PowerPoint
  • Excellent oral and written communication skills with the ability to communicate clearly and concisely to stakeholders and team members
  • Excellent problem-solving skills with the ability to recognize problems and take corrective action
  • Excellent teamwork skills with the ability to adapt to and influence diverse interpersonal ss; ability to influence and negotiate; ability to work in a rapidly changing environment