Pharmacovigilance Associate

CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. CATO SMS is a non-laboratory environment.

We are currently recruiting for Pharmacovigilance Associate to join our team in our Amsterdam Office with the option to work remotely in Europe.

Responsibilities:

Recording

• Create/maintain study-specific forms for collection of safety data (SAE forms, etc.)
• Document potential serious adverse event (SAE) information during intake of calls/email/fax
• Collect SAE forms from sites in cooperation with CRA(s)
• Review SAE forms received and determine if a follow-up query is required
• Contribute to the performance of initial safety review and triage of SAEs to determine seriousness, expectedness and priority, including the timeline for response
• Review and perform quality check of safety narratives summarizing all relevant medical information for individual case safety reports
• Review and quality check of process safety documents (Expedited Reports (CIOMs Forms), Annual Safety Reports (ASRs), etc.)

Safety data management

• Contribute to the performance of coding review of data from clinical study databases using standardized medical dictionaries (such as MedDRA)
• Liaise with the data management department to obtain required safety data and to provide safety input when required
• Support reconciliation of clinical and safety databases

Reporting

• Collect and perform quality control of safety documents to be reported to regulatory authorities, ethical committees and sites
• Submit safety documents to regulatory authorities and ethical committees according to regulatory requirements including the generation of safety letters
• Create/Maintain study tracking logs for regulatory submissions

RequirementsQualifications:

• Bachelor’s degree in Life science, healthcare and/or related fields
• Minimum 1 years of relevant work experience
• Minimum 1 years of experience in drug development and/or clinical research
• Thorough knowledge of GxP
• GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements

Skills:

• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required