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Vice President, Pharmacovigilance

Cambridge, Massachusetts 02139

Post Date: 02/05/2018 Job ID: 1783 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety

The Vice President of Pharmacovigilance will lead 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 Chief Medical Officer, 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.

Job  Responsibilities:
  • 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
  • Monitoring CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials
  • Overseeing new 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

Qualifications/  Requirements:
  • MD degree in a health science, with relevant clinical experience
  • Previous management or project management experience
  • Preferred minimum of 8-10 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

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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