Remote Pharmacovigilance Senior Specialist

Summary

Join our team and support the creation of individual case safety reports (ICSRs) for adverse drug reactions, ensuring timely and accurate delivery to competent authorities.

Requirements

• 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

Responsibilities

• Support creation of 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/MedWatch 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 timeliness
• 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