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Pharmacovigilance Scientist

2+ years
Not Disclosed
10 Aug. 7, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Responsibilities:

  • Adverse Event Management: Oversee the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for both marketed and investigational human and veterinary products. Ensure compliance with applicable regulatory requirements.

  • Aggregate Report Preparation: Prepare aggregate reports, including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, and US Periodic Adverse Drug Experience Reports (PADERs) from aggregate data. Ensure adherence to client conventions and requirements.

  • Quality Assurance: Perform quality checks of aggregate reports to ensure accuracy and compliance with regulatory standards.

  • Signal Detection and Analysis: Conduct signal detection-related analyses and prepare reports, including cumulative analyses and issue event analyses.

Minimum Qualifications:

  • Education: Master’s degree in Life Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, or Biophysics) or a degree in Dentistry. Alternatively, a Bachelor’s degree in Veterinary Sciences (B.V.Sc.) or a Post-Graduation in Veterinary Sciences (M.V.Sc.) is acceptable.

  • Experience: Experience in the Pharmacovigilance industry is preferred.

  • Skills:

    • Strong knowledge of medical terminology.
    • Fluency in written and spoken English.
    • Proficiency in computer use, including web-based applications and MS Office Suite (Word, Excel, PowerPoint).
    • Ability to work with Windows 10 or Windows 7 operating systems.
    • Capability to create concise, accurate, and relevant synopses of medical text and data.
    • Skill in writing clear and unambiguous medical text.
    • Ability to evaluate data independently and draw well-founded conclusions.
    • Strong written and oral communication skills.