Associate Director\/ Director, PV Operations
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 \u2013 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\u2019s 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\u2019 lives. SummaryThe Associate Director/Director reports directly to the Head of Global PV Operations and Quality. \u00A0Under the direction of the Head of Global PV Operations and Quality is responsible for all assigned PV Operations activities for both investigational and marked products in the BioMarin portfolio.\u00A0 ResponsibilitiesSupport Study Management Teams as an active member representing BPV Operations teamResponsible for review of study document, support reconciliation activities, participate in the conduct sponsored and Investigator Initiated trialsOversees PV Operations and PV vendor/service providers to ensure that they fulfill accountabilities and responsibilities, which includes:Responsible for assigned PV activities/projects Act as a Subject Matter Expert (SME) with regarding to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities Ensures that adverse events from spontaneous, solicited cases and studies and programs involving BioMarin products are collected, reported and handled in accordance with global/local regulatory requirements and company policiesResponsible for operational activities of ICSRs processed by PV vendors and provide feedback and guidance as applicable Functions as a PV advisor to Clinical Operations, Medical Affairs, Commercial and PV staffEnsures processes are followed to support on-time and appropriate ICSR submissionsProvides oversight for the preparation of expedited and aggregate safety reports (e.g., 15-day expedited reports, SUSARs, PSURs, PADERs, Annual Safety Reports, DSURs, IND Annual reports, etc.)Provides pharmacovigilance expertise to BioMarin and/or CRO/Vendor staff when neededPharmacovigilance related responsibilities for Patient Support Programs (PSPs), Market Research Programs (MRPs) and other service providers These activities include:Ensuring vendor oversight under the guidance of Head of Global PV Operations and Quality by contributing to creation, update and review of vendor agreementsLiaise with cross-functional colleagues to identify MRPs and PSPsProvide strategic input on the conduct of MRPs and PSPs to ensure compliance with PV requirements/regulationsRaises or increases awareness, knowledge and understanding of pharmacovigilance requirements by conducting/training session with functional partners/vendors as requiredAccountability for maintaining oversight of the PV Quality system, monitoring metrics to evaluate the PV Operations team on productivity/quality/compliance Overseeing the supporting implementation of CAPAs as necessary Under the direction of the Head of Global PV Operations and Quality, provide appropriate support during PV related regulatory inspection or internal auditsLine management for the Pharmacovigilance Specialists and Quality Manager.\u00A0 Provide coaching and identify opportunities for continuous improvement and self-development to optimize performance.\u00A0 Continuously assess resource needs.Perform other activities as directed by Pharmacovigilance management\u00A0Education & Experience \u00A0Minimum of 7 years previous Pharmacovigilance experience required and at least 4 years previous management experience requiredExpert knowledge in FDA, EMA, MHRA and other applicable global PV regulations Advanced knowledge of safety concepts and global regulatory reporting obligations and the ability to interpret and apply applicable regulations to resolve issuesWorks effectively, independently and collaborativelyStrong organizational skills, detail oriented and adapts in a dynamic, fast-paced environment Demonstrates ownership, initiative and accountabilityAbility to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team settingExcellent communication skills, both verbal and written, with credibility and confidenceSound strategic evaluation, analysis and decision-making skills as demonstrated in effective strategy formulation, tactics and action plans to achieve resultsDisplays a high level of commitmentBS/BA Degree in a health related or Life Science related field 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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