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Senior Safety Evaluation Scientist-Literature

8-10 years
preferred by company
11 Nov. 22, 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 Title: Pharmacovigilance Specialist – Literature Review

Key Responsibilities

  • Ensure timely production of deliverables, including:
    • Screening and reviewing literature search results (articles, abstracts, citations) for aggregate report inclusion and safety signal identification.
    • Maintaining up-to-date product knowledge to support literature reviews.
  • Manage resources effectively, ensuring a focused and balanced approach to workload.
  • Set business objectives, create development plans, and ensure all team trainings are completed.
  • Share pharmacovigilance and literature review knowledge with team members.
  • Coordinate safety-related findings, signal reviews, and documentation with SERM product specialists and physicians.
  • Monitor team performance against Key Performance Indicators (KPIs) for time, cost, quality, and compliance.
  • Assist direct reports with decision-making, problem-solving, and prioritization; provide management review and quality checks.
  • Perform quality checks for literature review outputs.
  • Lead or participate in process improvement activities.
  • Maintain good documentation practices and serve as the Point of Contact during audits or inspections.
  • Establish and maintain appropriate organizational networks.
  • Uphold and demonstrate GSK values.

Education Requirements

  • Minimum: Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or Pharmacology.
  • Preferred: Master’s degree or higher in Health Sciences.

Job-Related Experience and Skills

Experience

  • Pharmaceutical industry experience in areas such as drug safety, regulatory, clinical development, or medical affairs.
  • Exposure to post-marketing regulations applicable to drugs.
  • Experience in scientific literature review, data analysis, and interpretation.

Knowledge

  • Principles of causality assessment and safety signal evaluation.
  • Basic medical and drug terminology and therapy areas for assigned products.
  • Understanding of pharmacovigilance regulations and methodologies, including SERM activities.
  • Familiarity with relevant disciplines like pharmacoepidemiology and statistics.

Skills

  • Proficient in medical/scientific writing.
  • Strong English communication skills (written and verbal) with emphasis on scientific terminology.
  • Competent in evaluating data and drawing independent conclusions.
  • Detail-oriented with a high level of accuracy.
  • Strong interpersonal, presentation, and communication skills.
  • Proficiency in computer applications and web-based systems.
  • Flexible and skilled at prioritizing tasks.