Pharmacovigilance Senior Specialist

Remote
Full Time
Mid Level
ATTENTION Eastern US region and EST or CST time zones

Key Responsibilities and Activities
  • Support creation of Individual Case Safety Reports (ICSRs) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities
  • Support in the generation, processing, documenting, and tracking of follow-up requests
  • Ensure timely and accurate CIOMS / Med Watch deliverables
  • Assist with database reconciliation activities
  • Screening and documentation of scientific literature regarding safety relevant publications
  • Documentation of case processing on a company and a case level
  • Support Medical Information intake, documentation, QC, and reconciliation services
  • Handle customer inquiries or complaints according to quality assurance requirements
  • Monitoring of inbound mailboxes
  • Assist with case triage/guidance to case processing teams
  • Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
  • Lead Client and internal operational meetings to ensure quality, compliance, and timelineness
  • Contribute to/review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles, etc. for PharmaLex pharmacovigilance projects
  • Organize and perform training of the above-mentioned QA documents
  • Perform quality control tasks, e.g. ICSR processing quality checks, and other project-specific quality checks
  • Support initiation and closure of any project-related deviation and CAPA issues
  • Prepare for and participate in internal and external audits/inspections
  • Other duties as assigned

 
Required Education, Experience, Skills and Competencies
  • Bachelor’s Degree in Life Science, Nursing or Pharmacy and 5-7 years’ experience; or equivalent combination of education and experience
  • Minimum 5 years’ experience in CRO/Pharma/Biotech safety department
  • Excellent knowledge and experience of pertinent legislation/regulatory framework (GVP/CFR)
  • Strong clinical and post marketing pharmacovigilance experience
  • Ability to manage and execute on various safety-related operating procedures
  • Ability to prioritize work according to competing timelines and client needs
  • Demonstrated ability to work under tight timelines
  • Project management skills
  • Excellent customer service skills
  • Ability to adapt under regularly changing conditions
  • Very good command of English, written and verbal
  • Outstanding organization, analytical, and problem-solving skills
  • Excellent written, verbal and presentation communication skills
 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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