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Psur Report Authoring And Quality Review

5-6 years
Not Disclosed
10 Dec. 11, 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: PSUR Preparation and Review Specialist

Key Responsibilities:

  • Authoring and Reviewing PSURs:
    Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities, ensuring accuracy, completeness, and regulatory compliance.

  • Literature Search and Validation:
    Conduct literature searches to gather relevant data for PSUR preparation and validate the information to ensure accuracy.

  • Data Management:
    Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). Generate Line Listings (LL) from the safety database for PSUR inclusion.

  • Process Management:
    Manage and reconcile relevant process trackers to ensure all activities are documented and on schedule. Provide reliable support for high-priority ad-hoc activities related to PSUR preparation.

  • Client Interaction:
    Communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies and regulatory requirements. Ensure timely PSUR submissions.

  • Subject Matter Expertise and Training:
    Serve as a subject matter expert (SME) for PSUR preparation and review. Provide training and mentoring to team members on PSUR-related processes and regulatory requirements.

Qualifications:

  • Education: Bachelor's degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences); advanced degree preferred.
  • Experience: Experience in pharmacovigilance, drug safety, or related fields with a focus on PSUR preparation and review.
  • Skills:
    • Strong knowledge of regulatory requirements for PSURs/PBRERs.
    • Excellent analytical, problem-solving, and data interpretation skills.
    • Proficiency in safety databases and data extraction/validation processes.
    • Strong organizational skills and the ability to manage multiple tasks and projects.
    • Excellent written and verbal communication skills.
    • Ability to collaborate effectively with cross-functional teams and provide expert guidance.