Associate Director Safety Systems Program Lead; Global Safety and Pharmacovigilance

The Associate Director, PV Systems Project Manager establishes, executes, and upholds a comprehensive project management framework to propel priority Global Safety and Pharmacovigilance (GSPV) business endeavors related to PV technology and safety systems innovations and/or PV process improvements.

This role will lead cross-functional teams, collaborate with technical experts, and manage complex projects that deliver inventive solutions within approved budget, scope, and timelines to optimize PV systems and/or operations to gain efficiencies, improve quality, and/ or ensure continued compliance.

The role provides strategic inputs for business planning in alignment with R&D objectives. With strong R&D business acumen and IT Project Management experience, the Associate Director, PV Systems Project Manager understands the pharmaceutical software lifecycle and directs cross-functional efforts to implement and advance innovative technological solutions.

Responsibilities include: -

• Provide input into GSPV’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.
• 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.
• Lead project business case development, facilitate decision support, and shepherd project(s) through concept and approval phases, including finance approval.
• 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.
• Document and maintain comprehensive project plans that include detailed scope, timelines, resource allocation and budget plans.  Track actuals to ensure the timely, successful execution of priority projects and initiatives.
• Monitors project progress, identify risks and issues, and implement mitigation strategies to keep initiatives on track and deliverables on schedule
• Stays abreast of emerging PV technologies, industry trends and best practices.
• Interface with external vendors to ensure adherence to CSL values and policies while delivering quality results.

Educations, Skills and Competencies: -

• 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. 
• Certified Project Manager, PMP, PRINCE2 or Agile certifications a plus.
• 7-10 years in the biotech or pharmaceutical industry, including biomedical research organizations.
• 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.
• Proven track record as a project manager leading cross-functional teams in a global, matrixed environment, handling complex technical and regulatory challenges.
• Experienced in using standard project management tools, templates, and techniques such as critical path, milestone reporting, regular status reporting, variance analysis.
• Advanced understanding of medical, safety, and regulatory functions, with a focus on Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP).
• Proficient in IT Software Life Cycle processes, computer validation, and Quality Management Systems (QMS).
• Experienced in process design, SOP development, and training material creation.
• Familiar with GAMP5, 21 CFR Part 11, and other relevant industry regulations.
• Knowledgeable in international standards and regulatory requirements.
• Strong grasp of legal/regulatory compliance and quality management principles.
• Excellent attention to detail and ability to collaborate effectively in global, cross-functional teams.
• Proficient communication skills in English (verbal and written).

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

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