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Safety Analyst

None years
Not Disclosed
10 Jan. 15, 2025
Job Description
Job Type: Full Time Remote Education: BS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance (PV) Support Specialist
Location: Not specified
Industry: Pharmaceutical
Employment Type: Full-Time

Job Description:
This role supports the Pharmacovigilance (PV) Department by contributing to the scheduling and development of aggregate safety reports, risk management materials, and safety data compilation from clinical trials, spontaneous post-marketing reports, and other sources. It involves managing the operational aspects of aggregate safety reporting, conducting pharmacovigilance data analysis, and authoring periodic safety reports for clients. The role also supports signal detection and collaborates with stakeholders to ensure safety data outputs meet regulatory requirements.

Key Responsibilities:

  • PV Operational Support: Facilitate PV operational delivery and meet client deadlines for aggregate and signal reports, line listings, and safety data compilation.
  • Aggregate Safety Reporting: Manage and provide data analysis, authoring, and quality control (QC) for Periodic Adverse Drug Experience Reports (PADER).
  • Report Drafting: Support the drafting of aggregate reports such as Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Annual Safety Reports (ASR), and IND Annual Reports.
  • Collaboration: Work with various stakeholders to ensure that safety database outputs meet submission requirements while adhering to regulatory timelines.
  • Regulatory Compliance: Ensure understanding and adherence to safety reporting processes, safety management plans (SMP), and pharmacovigilance agreements (PVA).
  • Knowledge of Clinical Trial Methodology: Be familiar with drug development, post-marketing requirements, and pharmacovigilance regulations.
  • Database Familiarity: Work with safety databases (e.g., ARGUS, ARISg) and MedDRA.
  • Attention to Detail: Maintain a strong focus on the quality and completion of tasks.
  • Support PV Operations: Assist with PV audits, inspections, and drafting additional safety writing deliverables as required.

Minimum Qualifications:

  • Knowledge: Broad understanding of drug safety regulations and industry practices. Familiarity with FDA and international adverse event reporting regulations (per ICH guidelines).
  • Skills: Strong attention to detail, teamwork, and initiative.
  • Understanding: Knowledge of drug safety reporting and regulatory compliance.
  • Medical Terminology: Basic understanding of medical terminology and adverse event reporting.
  • Software Knowledge: Proficient in safety databases and Microsoft Office.

Preferred Qualifications:

  • Education: BS in a life science discipline (e.g., pharmacy, nursing).
  • Personal Traits:
    • Positive Attitude and Energy: Exhibits a motivated and energetic attitude.
    • Communication Skills: Strong ability to convey ideas and motivate others.
    • Innovator: Transforms creative ideas into impactful solutions.
    • Highly Principled: Demonstrates integrity and high moral standards.