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Medical Writer Ii

2+ years
Not Disclosed
10 Oct. 30, 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 Purpose:

The Aggregate Report Manager is responsible for managing both scheduled and unscheduled aggregate reports, including Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), and other critical safety documentation for investigational and marketed products. This role also involves generating line listings, performing regulatory submissions, and ensuring compliance with client requirements and international regulations.

Job Description:

  • Scheduling and Coordination: Organize meetings, draft agendas, track action items, and follow up on open issues.

Key Accountabilities:

Aggregate Reports Management:

  • Prepare and merge Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs), along with health authority response documents.
  • Manage a variety of aggregate reports, ensuring adherence to regulatory requirements and internal guidelines.
  • Conduct critical literature reviews to support the epidemiological data in safety reports.
  • Generate line listings to identify discrepancies and facilitate resolution.
  • Ensure high-quality documentation and compliance with internal and external timelines.

Clinical Study Report Narratives:

  • Liaise with the Study Management Team (SMT) to develop narrative templates and categories.
  • Serve as the primary client contact for narrative writing, addressing any related issues as needed.
  • Prepare accurate narratives based on clinical and safety database outputs, ensuring medical cohesiveness.
  • Conduct quality checks on narratives and assist with compilation and formatting.

Signal Detection and Management:

  • Conduct qualitative and quantitative signal detection reviews from various data sources.
  • Oversee the end-to-end signal management process, collaborating with the safety science team.

General Responsibilities:

  • Maintain an in-depth understanding of the adverse event profiles of assigned drugs and regulatory obligations.
  • Ensure readiness for audits and inspections.
  • Mentor new team members and manage workload distribution effectively.

Skills:

  • Strong analytical and problem-solving capabilities.
  • Excellent verbal and written communication skills.
  • Proficient in organizational and prioritization tasks.
  • Strong IT skills, including proficiency in MS Office and web-based applications.

Knowledge and Experience:

  • Relevant experience in Regulatory, Pharmacovigilance, or a related field is desirable.
  • Familiarity with medical terminologies is essential.

Education:

  • A university degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry).
  • A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with patient exposure is an advantage.

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