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Safety Writer - Aggregate Reporting (Ar)

3-5 years
Not Disclosed
10 Feb. 10, 2025
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

Department: Pharmacovigilance

Qualification:

  • Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or an equivalent field.
  • Fluency in English.

Mode of Work:

  • On-premise

Job Description:

  1. Aggregate Reports Management:

    • Serve as Advity’s primary contact and subject matter expert for aggregate reports.
    • Draft, retrieve, and analyze safety data from global safety databases for inclusion in Aggregate Reports (PADER, PSUR, PEBRER, RMP, DSUR, AdCo’s).
    • Ensure comprehensive and consistent aggregate analysis to establish the risk-benefit profile of products in compliance with Health Authority (HA) requirements.
  2. Cross-functional Communication & Coordination:

    • Effectively interact and communicate internally and cross-functionally in a matrixed environment.
    • Alert Medical Safety Physicians regarding potential safety issues and support them in monitoring product safety profiles.
  3. Quality Control & Compliance:

    • Conduct independent QC of Aggregate Reports to ensure completeness, consistency, and regulatory compliance.
    • Adhere to good documentation practices for audit and inspection readiness.
  4. Operational Excellence & Process Improvement:

    • Support projects related to operational excellence, including testing of safety systems and IT applications.
    • Contribute to process improvements driven by internal and external requirements.
  5. Pharmacovigilance & Safety Monitoring:

    • Review literature articles to identify case safety reports.
    • Perform operational Pharmacovigilance activities for assigned developmental and marketed products.
    • Assist in signal generation and safety analysis activities.
  6. Regulatory & Compliance Activities:

    • Support Health Authority inspections and audits.
    • Assist in developing Corrective & Preventive Actions (CAPA) to address safety findings.
    • Stay updated with current global Pharmacovigilance regulatory requirements.

This role requires strong analytical skills, regulatory knowledge, and the ability to collaborate effectively across teams to ensure product safety and compliance.