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Req ID: 24134 Job Category: Pharmacovigilance & Drug Safety Location: Boston, MA Posting Date: October 26, 2020 This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA or be remote/virtual, based anywhere in the United states and may require up to 20% travel.
The Associate Director, Global DS Operations Lead is responsible for ensuring the proper execution and implementation of Drug Safty Operational activities within Global Drug Safety, Study Management Teams, Clinical Operations, and other internal Alexion departments regarding the development of Alexion investigational and marketed products. The GDS Operations Lead plays a pivotal role within Global Drug Safety to ensure safety assessment for all Alexion investigational and marketed products. The candidate will provide scientific and compliance expertise as needed to GDS according to Alexion PV standards and processes.
Job Duties & Responsibilities
Responsibilities for this role include, but are not limited to:
Serve as a member of Global Development and post approval core team's subcommittee & teams
Collaborates with other Alexion departments and vendors to ensure data collection, analysis and reporting in Alexion interventional, non-interventional trials and IIT/ISR is in compliance with global regulatory requirements and Alexion SOPs Serves as an expert on pharmacovigilance global regulations, guidelines and industry best practices
Ensures compliance with health authority regulations with regards to data collection, analysis, reporting standards and operational consistency across interventional and non- interventional trials
Collaborates with members of the Case Management team to ensure critical or missing case information for appropriate
medical assessment is obtained and provided to PV vendor for the studies of their responsibility.
Works with CROs and clinical teams to ensure design of all trials enables timely processing and global regulatory compliance for all SAEs from assigned protocols
Provides oversight of SAE reconciliation activities between the clinical and safety databases in accordance with Alexion SOPs Responsible for performing initial analysis of safety data and reviewing / authoring safety section of Alexion's protocols and other safety related documents in collaboration with Medical Safety Physicians.
Collaborates with Clinical Operations, Data Management, Clinical CRO and Study Teams in development of the safety related data collection forms, table design, and listings for safety data from interventional/non-interventional trials and safety reporting plans (SRP)
Reviews and provides input and support with other departments (e.g., clinical operations, medical information, regulatory affairs, medical affairs, commercial CRO and data management) groups on GDS related topics for study protocols, statistical analysis plans and other clinical related documents
Ensures compliance with clinical trial activities as outlined in SRP and protocol and that proper documents are in place for monitoring
Ensures compliance and quality are maintained and issues are escalated appropriately and resolved Participates in product team, client and investigator meetings as requested or needed
Participates in and contributes to the continuous process improvement efforts and standardization of pharmacovigilance processes and methods
Assists with the creation and documentation of GDS training and conventions
Assists with the execution of CAPAS to minimize compliance gaps with the remit of role and responsibility Performs other duties related to the position as necessary as defined in SOPS and/or as request by Supervisor Serve as a SME for pre and post approval inspection for the studies/products under their responsibility Supports HA Inspections and internal audit activities.
Demonstrated proficiency in global regulatory requirements, guidelines and industry best practices for pharmacovigilance with experience in safety related organized data collection, analysis and reporting (e.g., interventional and non-interventional clinical trials, registries, patient programs, market research programs)
Expertise with Global Drug Safety databases (e.g., structure and conventions) Experience in MedDRA coding and search strategies
Strong people and project leadership skills Strong organizational and prioritization skill Strong analytical and problem solving sills
Strong communication skills, oral and written, including medical writing
Experience in safety data analysis and writing study related aggregate reports and safety assessments Literature search, evaluation and assessment skills
Presentation skills for conveying complex technical contents to non-expert audience Demonstrated commitment to quality and compliance
Demonstrated learning agility and ability to work independently, seeking advice as required
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
Understanding of clinical development processes related to clinical trials preferred
Bachelor's degree required, advanced degree in scientific or technical area preferred Minimum of 5 years' pharmaceutical experience, with at least 2 years in drug safety Advanced understanding of medical concepts and terminology
Demonstrated knowledge of global aspects of pharmacovigilance Experience in medical writing
Experience working in Drug Safety Database (ARGUS, ARIS-G, bespoke, etc)
Excellent attention to detail
Excellent oral and written communication skills
Analytic and strategic thinking in complex multi-cultural situations
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years,Alexionhas developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).Alexionalso has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor.Alexionfocuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered inBoston, Massachusetts,Alexionhas offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com .
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
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