This listing was posted on Professional Diversity Network.
Manager, Drug Safety
Location:
Cambridge, MA
Description:
Job Description Duties: Responsible for the oversight of global case processing activities in both the Post- Marketing and Clinical Trial settings. Support Case Processing Oversight Associate Director to ensure AE and SAE case processing is compliant with regulatory requirements and corporate and departmental procedures. Manage the case processing vendor responsible for serious post-market case processing by leading regular operational and check-in calls, participating in Case Delivery Compliance and Case Quality Collaboration meetings, responding to case processing related communications, performing oversight review, identifying trends in quality and case delivery compliance and subsequent training needs, reviewing business object reports to ensure cases are processed in accordance with contractual obligations, and providing input on the vendor-owned business plan and the marketed product safety management plan. Ensuring implementation of effective Corrective and Preventive Action (CAPA) Plans and follow-up effectiveness checks as needed. Reviewing and providing input on vendor-owned quality event reports, including suggesting actions for vendor to take to correct and prevent future quality events of the same nature. Working within the Global Case Management (GCM) team and cross functionally across Global Safety and Regulatory Sciences (GSRS) to develop/review governing documents (e.g., SOPs, job aids, etc.) and training materials. Supports process or efficiency improvement projects inclusive of Global Safety Database (GSD) upgrades (major/minor), User Acceptance Testing (UAT), vendor training, and automation initiatives. Acting as subject matter expert on operations and oversight of AE case processing partners during audits/inspections. Acting as a qualified trainer for colleagues training on the GSD. Leading initiatives supporting the transition of activities from Biogen Case Processing Oversight team to the vendor, such as Logical Case Deletions. Coordinating and leading regular meetings liaising with Patient Services representative with a focus on improving the quality of call log reports entered into the remote data capture system. Providing direct supervision of contractors and mentoring junior staff within the Case Processing Oversight team. Telecommuting permitted. Qualifications Minimum Requirements : Bachelor's degree (or foreign equivalent) in Nursing, Pharmacy, other Health Care related or Life Sciences discipline, or a related field. 4 years of experience in pharmacovigilance in a biotech or pharmaceutical industry setting.Candidate must also have 36 months of experience in the following: Demonstrating a comprehensive understanding of pharmacovigilance and drug development, including knowledge of global clinical trial safety regulations and post- marketing safety regulations. Performing TrackWise Late Case Investigation write-up, approvals, and subsequent CAPA review. Preparing and leading governance meetings with contract research organizations (CROs) monitoring contractual KPIs. Using MS Access for oversight review. Performing UAT for ARISg and agTracker scripts. Acting as qualified trainer in ARISg version and agTracker. Identifying requirements and running Business Objects Reports. Performing review and approval of Functional Requirement Documents and User Requirement Documents. Liaising with Reporting and Submissions functions for Distribution Rules. Liaising with International Pharmacovigilance team. Leading initiatives focusing on efficiency gains and improvements. Proven ability to remediate CRO underperformance. Conducting global business continuity testing with affiliates and vendors. Supporting audits and inspections. Interacting with third parties including vendors. Demonstrating effective leadership in a high pressure, fast-paced cross-functional team environment with individuals across all levels within an organization. Working effectively with a diverse team and a geographically distributed environment. Demonstrating the ability to effectively communicate information orally and in writing, including explaining methodology and consequences of decisions in lay terms to internal and external stakeholders and senior management. Building effective cross-functional and cross-team relationships across and up and down a matrix organization, and partnering with other functions as well as internal and external stakeholders. Demonstrating basic knowledge of common data processing software (including Microsoft Excel, PowerPoint, and Word, and Business Objects) and common safety database systems (including ARISg and agTracker). Additional Information All your information will be kept confidential according to EEO guidelines. Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9c4413d6-d006-42fe-b724-b8a57603b352
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