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BioMarin is looking for an individual with experience working in Pharmacovigilance (PV) within the space of Quality and Compliance. This important role will be joining our Global Quality organization and reports into the Head of R&D Compliance. This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and leads a team who collectively assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The GVP Compliance Lead partners with the GCP and GLP Compliance leads to ensure oversight and timely execution of the BioMarin R&D Audit Program. This individual is also a key point of contact supporting the planning and execution of GVP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues.
Job Responsibility:
Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates
Core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
Create a high-functioning team to ensure GVP compliance and foster a culture of teamwork and mutual respect
Mentor and develop staff to achieve their full potential
Conduct management activities, including staffing, budget monitoring, and strategic planning
Manage recruiting, hiring, and evaluations with HR and Global Quality leadership
Requirements:
10+ 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 Pharmacovigilance 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 leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
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
Bachelor’s Degree within a life science focus area
Nice to have:
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)
master’s degree is a plus
What we offer:
company-sponsored medical, dental, vision, and life insurance plans
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