Drug Safety Manager (Project Management)

Drug Safety Manager (Project Management)

TFS HealthScience

Home-based or Warsaw, Poland

Job Purpose

The Project Manager will have the overall responsibility for managing safety clinical projects (post-marketing experience is advantageous as well) in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.

The Project Manager may assist other Project Managers in the identification of critical project task/issues and recommend course of actions to expedite project objectives and function as a project senior-level governance contact for issue escalation matters.

Essential job functions:

  • Ensure that projects are delivered on-time, within scope and within budget and in compliance with applicable quality standards
  • Manages the strategic aspects of projects and identify, analyze and minimize/mitigates any risk, including the implications of difference technical and operational choices.
  • Communicates effectively with clients to successfully manage the relationship, identify needs and evaluate alternative business solutions and strategies.
  • Develop and maintain Project Plans and timelines for their project and track progress
  • Ensure all study team members are adequately trained on project specific systems and procedures
  • Develops, implements, and maintains sound business practices
  • Measure and evaluate project performance
  • Manage the project budget, profitability and ensure invoicing is performed on time and in accordance with the scope of work
  • Working with the Finance & Accounting team to analyze profitability, revenue, margins and utilization across their projects.
  • Manage the resource allocation, on the project, in collaboration with respective line managers
  • Facilitate internal and external communication
  • Report and escalate to management as needed
  • Establish and maintain relationship with third parties/vendors
  • Manages high-level deliverables across the organization
  • Participate in capability presentations/bid defenses, as needed
  • Continually defines ways to increase customer satisfaction and deepen client relationships.
  • May provides leadership, guidance and support for Business Development opportunities, including participating in business proposal generation and final review process.
  • Contribute in review/develop procedures, guidelines, SOPs, metrics as needed
  • Provide performance feedback of the team members to the corresponding manager

Requirements

  • Bachelor’s Degree, preferably in life science or nursing; or equivalent
  • 3-5 years of relevant Drug Safety experience
  • Understand the medical terminology and science associated with the assigned drugs and therapeutic areas
  • Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
  • Excellent English written and verbal communication skills

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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