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Associate Director Safety Systems Program Lead; Global Safety and Pharmacovigilance
2 months ago
The Associate Director, Safety Systems and Pharmacovigilance is a strategic leader responsible for establishing, executing, and upholding a comprehensive project management framework to propel priority business endeavors related to safety systems innovations and/or process improvements.
Key Responsibilities- Strategic Planning: Provide input into the company's 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.
- Project 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. Lead project planning, execution, and oversee all aspects of the future solution to meet business goals.
- Business Case Development: Lead project business case development, facilitate decision support, and shepherd project(s) through concept and approval phases, including finance approval.
- Project Execution: 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.
- Project Monitoring: 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 Seqirus values and policies while delivering quality results.
- 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.
- IT Project Management: Minimum of 7 years of IT Project Management experience with extensive knowledge in drug research, development, and manufacturing (CMC, non-clinical, clinical, regulatory); PV experience is preferred.
- Leadership: Proven track record as a project manager leading cross-functional teams in a global, matrixed environment, handling complex technical and regulatory challenges.
- Technical Skills: Experienced in using standard project management tools, templates, and techniques such as critical path, milestone reporting, regular status reporting, variance analysis.
- Regulatory Knowledge: Advanced understanding of medical, safety, and regulatory functions, with a focus on Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP).
- Quality Management: Proficient in IT Software Life Cycle processes, computer validation, and Quality Management Systems (QMS).
- Process Design: Experienced in process design, SOP development, and training material creation.
- Regulatory Compliance: Familiar with GAMP5, 21 CFR Part 11, and other relevant industry regulations.
- International Standards: Knowledgeable in international standards and regulatory requirements.
- Communication Skills: Excellent attention to detail and ability to collaborate effectively in global, cross-functional teams.
- Language Skills: Proficient communication skills in English (verbal and written).
