Safety Specialist II

Location

Serbia

Posted

9 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishOracle

Job Description

Safety Specialist II

Precision For Medicine

• Perform 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 • Participates 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

Job Requirements

  • 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

Benefits

  • Health insurance
  • Flexible work arrangements

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