Medical Director, Pharmacovigilance

Acceleron Pharma   •  

Cambridge, MA

Not Specified years

Posted 244 days ago

This job is no longer available.

Medical Director, Pharmacovigilance

Clinical Development  Cambridge, MA

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Description

Who are we? Acceleron is a Cambridge-based, 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 biology and protein engineering enables the generation of innovative compounds that engage the body’s ability toregulate 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 franchisewith two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary program with a Phase 2 trial of sotatercept planned in pulmonary arterial hypertension. What’s in it for you? The Medical 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 willinterface 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 withWHO-ICH guidelines and the appropriate regulatory agencies, including FDA
  • Developing and implementing SOPs and other controlled documents to supportinvestigational and marketed product safety surveillance
  • Identifying and analyzing safety signals
  • Performing aggregate analyses of specific events across studies, as indicated
  • 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 degree in a health science, with relevant clinical experience
  • Previous management or project management experience
  • Preferred minimum of 3-5 years total experience in US and/or international pharmacovigilance/drug safety, or equivalent relevant clinical development experience in Pharmaceutical and/or Biotechnology industry
  • Expert 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
  • Ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors
  • Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams
  • Demonstrated leadership skills and ability to influence across external functions and within internal team