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Strategic Project Manager for Global Safety and Pharmacovigilance

2 months ago

Reading, Reading, United Kingdom CSL Seqirus Full time
Job Summary

We are seeking a highly experienced Associate Director to lead our Global Safety and Pharmacovigilance team. As a key member of our organization, you will be responsible for establishing, executing, and upholding a comprehensive project management framework to propel priority business endeavors related to PV technology and safety systems innovations and/or PV process improvements.

Key Responsibilities
  • Strategic Planning: Provide input into our long-range technical roadmap, considering the current system landscape and strategic objectives for Pharmacovigilance, including research on emerging trends and technologies to further optimize internal capabilities.
  • Team Leadership: Lead, influence, and mobilize transversal teams of subject matter experts to foster collaboration, gain alignment on 'to be' process/data maps, and drive shared accountability towards common goals.
  • Project Management: Lead project planning, execution, and oversee all aspects of the future solution to meet business goals, including project business case development, decision support, and project(s) through concept and approval phases.
  • Methodologies and Best Practices: Utilize well-established and novel project management methodologies and best practices to drive efficient and effective project execution, ensuring quality, consistency, and adherence to project requirements.
  • Documentation and Tracking: Document and maintain comprehensive project plans that include detailed scope, timelines, resource allocation, and budget plans, tracking actuals to ensure the timely, successful execution of priority projects and initiatives.
  • Risk Management: Monitor project progress, identify risks and issues, and implement mitigation strategies to keep initiatives on track and deliverables on schedule.
  • Industry Knowledge: Stay abreast of emerging PV technologies, industry trends, and best practices.
  • Vendor Management: Interface with external vendors to ensure adherence to CSL values and policies while delivering quality results.
Requirements
  • Education: Bachelor of Science in Engineering, IS/Computer Science, or Data Analytics Degree (BSc/MSc/Diploma), Quality or Operations Management, Management Information Systems, or Business Analytics or equivalent is essential.
  • Certifications: Certified Project Manager, PMP, PRINCE2, or Agile certifications a plus.
  • Experience: 7-10 years in the biotech or pharmaceutical industry, including biomedical research organizations, with a minimum of 7 years of IT Project Management experience and extensive knowledge in drug research, development, and manufacturing (CMC, non-clinical, clinical, regulatory).
  • Skills: Proven track record as a project manager leading cross-functional teams in a global, matrixed environment, handling complex technical and regulatory challenges, with advanced understanding of medical, safety, and regulatory functions, and proficient in IT Software Life Cycle processes, computer validation, and Quality Management Systems (QMS).