Job code: SPH-PM01-2018

Essential Duties And Responsibilities: 

  • Successful application of project management expertise to define project scope, strategy and risks.

  • Understand and finalize project requirements in collaboration with client and Sophos project teams.

  • Manage the complete life cycle of Drug Safety System implementation including budget, resources, quality, schedule, risk mitigation and project execution.

  • Ensure successful project delivery within the agreed timeframe and budget, maintaining the quality standards and regulatory compliance.

  • Create and manage resource estimators to track allocation, load and productivity.

  • Ensure compliance with Sophos and client’s (as applicable) Standard Operating Procedures, policies and guidelines.

  • Develop proposals against RFPs, review assigned SOWs, contracts, manage contract amendments and work orders as required.

  • Contribute during audits and inspections for assigned projects.

  • Collaborate with Sophos’ quality team to assist in the creation of work instructions, policies and corrective/preventive action plans as needed.

  • Guide and mentor direct reports in providing best in class project management support to client and internal projects.

Minimum Education Qualification, Specialized Knowledge and Skills: 

  • BS degree or higher

  • Minimum 7 years’ experience in Project Management, account handling, or equivalent experience specifically in Life Sciences / PV Domain.

  • Project/Program Management certification.

  • Understanding business needs with global PV perspective.

  • In-depth experience of working in a regulated space (pharmaceutical industry, particularly pharmacovigilance).

  • Good understanding of applicable global and regional regulatory requirements and ICH guidelines.

  • Working knowledge of Drug Safety system(s) and functional activities.

  • Strong leadership skills and learning agility.

Primary Work Location

United States


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