Medical Director Pharmacovigilance
Brisbane, CA
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives. MEDICAL DIRECTOR PHARMACOVIGILANCESafety Strategy and Planning Participate in the development of safety surveillance and risk management plans for drug development programs. Provide safety advice and inform Pharmacovigilance senior management as appropriate. Review any literature or regulatory changes affecting pharmacovigilance and assess impact on BioMarin product safety plans and risk managementSafety Surveillance Support the performance of medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving BioMarin products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting. Assist in follow-up of important ICSRs to ensure relevant information is sought. Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals. For development products, contribute to the review and drafting of safety related sections in study specific documents such as Protocol, IB, CSR as appropriate Support preparation for Study Management Team meetingsSafety Reporting and Documentation Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report). Participate in the preparation and revision of company product labeling and RMP as appropriate. Review and advise on safety/medical information in advertising and promotional materials as needed. Help prepare and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/MA/BLA/CTD submissions and other Support the authorship of responses to regulatory authority safety-specific inquiries; Support the authoring and/or providing input to PharmacovigilanceCross functional Leadership Participate as the BPV representative on Clinical Study Execution Teams (SET) for development products and/or Medical Affairs Project Team (MAPt) for commercial products as applicable focusing on protocol and ICF review, SRP development, safety reporting training and SAE reconciliation.Additional Responsibilities Participate in functional activities and projects aimed at improving BioMarin Safety planning and surveillance capabilities Authoring and/or providing input to Pharmacovigilance policies and standard operating procedures Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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