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Cambridge, MA, US
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Who are we?
Acceleron is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.
Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in facioscapulohumeral muscular dystrophy and Charcot-Marie-Tooth disease and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.
What’s in it for you?
Director of Pharmacovigilance will contribute importantly to the strategic management, planning, and execution of Clinical Pharmacovigilance and risk management for early and late stage clinical development programs in compliance with the appropriate regulatory guidelines. Reporting to the VP, Medical Research/ Head of Pharmacovigilance, this hire will interface with various functional areas and external resources, collaborating with clinical, regulatory, contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety pharmacovigilance is performed adequately across all ongoing clinical trials.
What will you be doing?
Organizing and overseeing product safety surveillance and evolving safety profiles for clinical development of our products
Reviewing and approving drug safety information from clinical sources in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA
Developing and implementing SOPs and other controlled documents to support investigational and marketed product safety surveillance
Identifying and analyzing safety signals
Performing aggregate analyses of specific events across studies, as indicated to support TA-specific semiannual safety review team (SRT) as well as company-wide quarterly safety review committee (SRC) meetings
Monitoring CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials
Contributing clinical/safety expertise by providing content for drug application safety updates, investigational new drug safety reports, investigator communications, Development Safety Update Reports (DSURs) and other reports as necessary
Participating on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content
Developing and implementing Pharmacovigilance training programs for both internal and external use
Liaising with Medical Research, Clinical Operations, Regulatory Affairs and Quality to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders
Implementing, executing, and maintaining safety processes and systems
Monitoring industry best practices and global safety regulations to ensure continuous compliance
Preparing for regulatory inspections and audits and developing corrective action plans when needed
What are we looking for?
MD, PharmD, PhD, MS, BS, RN, or RPh degree in a health science, with relevant clinical experience
Previous management or project management experience
Preferred minimum of 5 years total experience in US and/or international pharmacovigilance/drug safety, or equivalent relevant clinical development experience in Pharmaceutical and/or Biotechnology industry
Experience and familiarity with safety databases such as Oracle Argus and/or ARISg
Must have demonstrated working knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’s related to pharmacovigilance (e.g.E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
Has the capacity to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams
Has the ability to work independently with minimal supervision, multi-task with attention to detail, manage multiple projects under tight deadlines, and independently identify problems and effectively offer solutions
How will you grow with us?
This opportunity will allow you to help drive the Pharmacovigilance function at Acceleron while being part of a talented team and collaborating with knowledgeable and passionate team members. This position will enjoy and benefit from very broad therapeutic area exposure, including within the hematologic, pulmonary and neuromuscular therapeutic areas. Further disease area exposure is possible depending on future TA prioritization at Acceleron. It is an exciting time to work at Acceleron, with our company growth and advancing drug pipeline. You will tackle exciting challenges in a fast-paced environment working with other professionals dedicated to applying our technology to improve the lives of patients with a wide spectrum of disease while further developing our drug safety and risk management practices. Grow in your career and join our team!
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
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