Associate Director, GVP Compliance
HybridLondon, England, United Kingdom
Job Summary
Execute GVP audits and assess compliance with global regulations, corporate policies, and standard operating procedures. Advise internal and external stakeholders on Good Pharmacovigilance Practices and act as a key point of contact for regulatory inspection readiness and execution. Collaborate with stakeholders to identify, communicate, and mitigate compliance risks while performing GVP audits and contributing to the Global GVP Audit Program. Contribute to Pharmacovigilance System Master File updates, Risk Evaluation and Mitigation Strategies compliance, and the development of junior staff. Work independently to resolve regulatory compliance issues and optimize the audit program.
Required Qualifications
- 8+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
- Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovilance Practices (GVP), ICH and GCP regulations
- Experience working in Pharmacovigilance (PV) within Quality and Compliance
- Experience executing or managing Health Authority Inspections
- Experience executing or managing R&D Audits and GVP Audit Program
- Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
- Experience navigating and understanding a quality management system
- Core competencies in strategic thinking, agility, prioritization, communication and decision making
- Strong verbal, written and oral communication skills. Able to present to Senior Leadership
- Able to work independently and be flexible to rapidly changing priorities
- Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems
- Must be available for at least (2) days per week onsite following the hybrid role requirements
- May travel up to 25%+ of the time
Desired Qualifications
- Bachelor's Degree within a life science focus area
- master's degree is a plus
- Experience with Business Development partnerships, mergers and/or acquisitions
- Exposure to working in any phase of pharmaceutical drug development or post-marketing surveillance of medicines
- Awareness and understanding of core PV responsibilities i.e., risk management, risk minimization measures, signal management, and case processing
- Compliance oversight of REMS Program(s)
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