Business Strategist for Pharmacovigilance and Regulatory Compliance
1 week ago
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.
Job Description:The Senior Director Quality Business Partner: Pharmacovigilance and Regulatory role is an exciting opportunity to develop and deliver quality strategies in Pharmacovigilance and Lifecycle Management, ensuring regulatory compliance and patient safety.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. Responsibilities include:
- Developing and delivering the quality strategy for Pharmacovigilance and Lifecycle Management activities.
- Managing a small team of Quality Business Partners.
- Providing assurance to GSK R&D senior management that GSK processes for managing safety data are effective.
Key Responsibilities Include:
- Functional Expertise:
- Direct accountability for the quality strategy for Safety, Regulatory and post marketing activities.
- Continually evaluate the strategic approach, drive changes in R&D QuRE processes.
- Identify and drive continuous quality improvements as a consequence of risk assessments.
- Leadership/People Management:
- Build and maintain a Pharmacovigilance & Lifecycle Management Quality team.
- Provide leadership, professional development, mentoring and coaching for direct and indirect reports.
- Others:
- Lead multidisciplinary or cross-functional work/project teams.
- Provide guidance and expectations to the business to enable execution of external regulations and internal standards.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree or equivalent in scientific or quality-related field.
- Experience in drug development, pharmacovigilance operations, regulatory compliance or quality management.
- Knowledge of GCP, pharmacovigilance/drug safety and regulatory requirements.
The estimated salary for this position is approximately $120,000 per year, based on industry standards for similar roles in the UK area.
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