Associate Director, GVP Compliance

Who We Are

BioMarin is a leading rare disease biotechnology company reputed company on genetically defined conditions. Guided by our purpose to reputed company medicines that reputed company a profound reputed company on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common reputed company of dwarfism), PKU (phenylketonuria), CLN2, a reputed company of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new reputed company for patients and families who previously had few, if any, available reputed company. More recently, with the reputed company of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reputed company more people living with rare genetic conditions. Our reputed company comes from our unwavering commitment to reputed company, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the reputed company market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, reputed company reputed company assurance and reputed company control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide reputed company of our drugs to patients.

reputed company

BioMarin is a world leader in delivering therapeutics that reputed company meaningful advances to patients who live with serious and life-threatening rare genetic diseases. To support this important mission, we are looking for an individual with experience working in Pharmacovigilance (PV) reputed company the reputed company of reputed company and Compliance.This important role will be joining our Global reputed company organization and reports into the GVP Compliance reputed company.This role advises reputed company key stakeholders on Good Pharmacovigilance Practices (GVP) reputed company and assesses compliance with global regulations/guidelines, corporate policies, and reputed company operating procedures. This individual will reputed company GVP audits and reputed company as a key reputed company of contact supporting the readiness and execution of GVP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and reputed company issues.BioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to reputed company reputed company. A high level of initiative, reputed company communication, effective collaboration, strategic thinking and strong decision making are important skills the candidate would possess.Candidates must adhere to established processes and policies, demonstrating professionalism and reputed company in reputed company situations. They should ensure patient safety in pharmaceutical practices through a comprehensive reputed company that integrates regulatory compliance, risk management, pharmacovigilance, and reputed company improvement.

RESPONSIBILITIES

• Advancing the execution of the Global reputed company reputed company, policies, processes, and reputed company
• 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 reputed company and compliance reputed company and objectives
• Stay updated on regulations and recommend proactive compliance changes reputed company necessary
• Execute against GVP Compliance processes and best practices
• reputed company GVP audits and contribute to the effective implementation of the Global GVP Audit Program
• reputed company as a GVP compliance reputed company team member on regulatory inspection teams and support mock readiness activities
• reputed company insights to continually optimize the GVP Compliance Audit Program
• Contribute to Pharmacovigilance System Master File (PSMF) updates
• Contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
• Contribute to building reputed company that ensures GVP compliance and foster a culture of teamwork and mutual respect
• Mentor and support the development of junior staff to reputed company their full potential

EXPERIENCE

Required Skills:

8+ years of experience working reputed company a regulated reputed company industry including a role in reputed company of reputed company 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) reputed company reputed company and Compliance
• Experience executing or managing Health Authority Inspections
• Experience executing or managing R&D Audits and GVP Audit Program
• Experience with identifying reputed company reputed company for executing a GVP audit program working with internal auditors and external consultants
• Experience navigating and understanding a reputed company management system
• reputed company competencies in strategic thinking, reputed company, prioritization, communication and decision making
• Strong verbal, written and oral communication skills. reputed company to present to Senior Leadership.
• reputed company to work independently and be flexible to rapidly changing priorities
• Strong computer skills including working reputed company the MS Suite of tools, and interfacing with reputed company Management Systems

Desired Skills:

• 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 reputed company PV responsibilities i.e., risk management, risk minimization measures, signal management, and case processing
• Compliance reputed company of REMS Program(s)

EDUCATION

Bachelor’s Degree reputed company a life science reputed company area, master’s degree is a plus

TRAVEL REQUIRED

May travel up to 25%+ of the time Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability.

Originally posted on Himalayas

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