Drug Safety

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.·
Supervision of, collaboration with, and delegation to other members of the pharmacovigilance team to facilitate day-to-day drug safety activities.·
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.
REQUIREMENTS
M.D. or PhD with experience

Pharmaceutical industry pharmacovigilance experience required including ex-U.S. requirements and strategies.·
Up-to-date knowledge of GCP, ICH and CFR requirements.·
Outstanding leadership and team skills required.·
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.