BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.
Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.
EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 09-0060
SUMMARY
BioMarin is seeking an individual to direct the company’s overall pharmacovigilance program that consists of safety reporting for all clinical stage and commercial products on a world-wide basis. Experience and in-depth knowledge of the FDA and international drug safety regulations, collaborating with regulatory affairs to complete necessary safety reporting and follow-up measures, management of the company safety database, outsourcing of ex-US safety reporting through contract vendors, oversight of a company-wide safety committee, and managing a staff of internal safety personnel are key requirements for this position. Key internal interactions will include interface with Clinical Affairs, Regulatory Affairs, Commercial Operations, Corporate Compliance and Executive level personnel.
RESPONSIBILITIES
• Supervision of, collaboration with, and delegation to other members of the pharmacovigilance team to facilitate day-to-day drug safety activities
• Insure compliance with all regulatory reporting requirements and timelines for safety data, and proactively assess and address safety issues for all products in clinical development or commercialized by BioMarin.
• Collaborate with Regulatory Affairs in the preparation and revision of product labeling and company core data sheets, submission of safety reports, and meetings of the safety committee to review possible data signals.
• Collaborate with Data Management, Compliance and IT to establish systems and controls using in-house and outside vendors to direct all safety data from commercial sources and clinical studies to a single database.
• Collaborate with Medical Directors in both Clinical Affairs and Medical (Commercial) Affairs to provide expertise in both U.S. and ex-U.S. post-marketing activities, focusing on education of the medical community and interaction with regulatory agencies.
• Insure that promotional or business-related materials provide a consistent characterization of safety events in interactions with the investigators, internal and external collaborators, consultants and contract resources.
• Review and approval of safety sections of protocols, informed consent forms, clinical study reports, annual progress reports, and other documents as needed.
• Participation in product-specific teams.
• Interface with corporate partners in the exchange and presentation of safety information.
• Contribute both strategic and tactical contributions to the overall product development plans as established by the Product Approval Committee.
• Represent the company at scientific, industry and financial community meetings and presentations, as well as other public relations opportunities.
• Anticipate and adapt to change while maintaining the momentum of an overall strategic plan.
EDUCATION
Bachelors or Masters degree in relevant field with the appropriate safety experience.
EXPERIENCE
• Outstanding leadership and team skills required.
• Pharmaceutical industry pharmacovigilance experience required including ex-U.S. requirements and strategies.
• Up-to-date knowledge of GCP, ICH and CFR requirements.
• Outstanding presentation skills, written and oral, required.
• Collaborative and flexible in personal interactions at all levels of the company.
• Ability to work proactively and effectively, with exceptional creative problem solving skills.
• Excellent strategic planning, organizational and communication skills.
To apply: Visit www.BMRN.com Job Code 09-0060
- Compensation: DOE
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