Safety Specialist II

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Overview

Position Summary: The Safety Specialist II is an integral part of the safety team at Precision and performs all aspects of the collection, processing,

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OtherSafety Specialist

The Safety Specialist II is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.

Process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans
Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
Enters data into Argus Safety Database
Code events, medical history, concomitant medications and tests.
Draft case narratives
Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements
Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
Participate in audits/inspections as required
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
Attends Department meetings
Participates in project specific teleconferences/meetings as required
Other duties assigned by management

Requirements

~1 min read

Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
Bachelor’s or first-level Degree in Pharmacy or Nursing preferred, but other Life Science, or other health-related field, or equivalent qualification.  Immuno-oncology and Advanced Therapy Medicinal Products experience a plus.
Experience with Oracle Argus Safety Database
Working knowledge of MedDRA and WHODrug
Working knowledge of FDA safety regulations, EMA.MHRA and other ICH guidelines, and global safety regulations

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