OverviewAlnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. Alnylam currently has tree commercial RNAi therapeutic products. The first product is approved in the U.S., EU, Canada, Japan, and Switzerland for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults and the second product is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). Alnylam also has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,600 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2019 and Science Magazine’s #1 Top Employer in 2019. Please visit www.alnylam.com for more information.The Associate Director, PV Science is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will oversee risk management plan activities including signal tracking maintenance, adhoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Alnylam products.
Summary of Key ResponsibilitiesLead with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.Knowledge of literature review supporting signal detection.Accountable for quality of the medical authoring of assigned product summaries and reports.Responsible for coordinating and developing Risk Management Plans (RMPs) for Alnylam products among multiple stakeholders. Participate in the collection and analysis of data related to status and measurement of the effectiveness of risk management initiatives.Responsible to work with product physician, affiliate management and regulatory to develop and edit Safety Management Plans /ESRPs and independently bringing issues related to these documents for discussion with impacted parties.Work with Regulatory to ensure submission plan for regulatory documents.Contribute to signaling and data mining activities utilizing internal and external sources of data. Strong knowledge of capabilities and limitations of various data sources. Assist in the planning and evaluation of potential safety issues and quality risk assessment reports.Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues. With oversight from product safety lead physician, responsible for analysis, collation and presentation of safety data to multi-disciplinary safety teams.Contributes to SOP and template development and maintenanceContributes to the development the development of, work practices and guidelines, forms and templates, and other communications related to risk management and product safety. Act as a subject matter expert for GPSRM processes and tools - for ensuring the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management processes. - and implements innovative strategies and/or process improvements under direction of Senior members of GPSRM - as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritization, budget management and forecasting. - expertise with data visualization tools (eg. Empirica, Spotfire) - and support the authoring for aggregate safety reports (eg. PBRERs, DSURs) in close collaboration with medical, medical writing and operational functions - management and training for new staff on department practices and therapeutic area knowledge.
Participates in inspection-readiness activities and inspections as requiredQualifications
Education: Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
Experience: Prefer three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in rare diseases therapeutic area at a global level is an advantage. Strong skills and experience in; - the development and application of business process improvement methodologies and/or developing ideas into practical business solutions. - to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures. - safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs. - of Argus, Arisg Safety Databases - of Signaling tools (eg. Empirica, Spotfire) - in regulatory Inspection readiness in regulatory inspections - skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements Strong planning, organization, written and oral communication skills Experience in clinical patient care a plus - knowledge: - science, disease, and understands the interdependencies of the studies within the program and the study strategy - relationships with other EAs within Clinical Development, Regulatory Affairs, Nonclinical, GPSRM, and Medical Affairs - knowledge in ICH GCP, Drug development process and regulations
Skilled in using Word, Excel, PowerPoint, reference management, and EDMSExperience in literature review for assigned products
Special Skills: Ability to represent the functional department as primary internal and external contact on contracts and delivery for services relating to drug safety risk management. Lead cross-functional briefings and technical meetings for project stakeholders and customer representatives. Strong negotiation skills encouraging discussion and driving decisions to desired results. Strong analytic and scientific writing abilities.
Job Complexity: Involved in RMP and Aggregate Report Management. Managing through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to risk management.
Supervision: Individual is expected to work independently with support from management and colleagues in GPSRM.
