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Medical Writer I

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Remote 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 the management of scheduled and unscheduled aggregate reports, including Periodic Safety Reports (PSRs), Periodic Benefit-Risk Evaluation Reports (PBRERs), 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.

Key Accountabilities:

Aggregate Reports Management:

  • Prepare, update, and merge Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs), along with health authority response documents as per client specifications.
  • Manage the preparation of various aggregate reports, including PSURs, PBRERs, Development Safety Update Reports (DSURs), and others, ensuring alignment with regulatory and client guidelines.
  • Conduct critical literature reviews to support epidemiological data in safety reports.
  • Generate line listings to identify discrepancies and ensure resolution.
  • Ensure high-quality documentation and compliance with internal and external timelines.

Clinical Study Report Narratives:

  • Create accurate narratives based on clinical and safety database outputs, ensuring medical cohesiveness and adherence to guidelines.
  • Perform quality checks on drafted narratives and assist in their compilation and formatting.

Signal Detection and Management:

  • Conduct signal detection reviews and manage the end-to-end signal management process in collaboration with the safety science team.
  • Support signal detection activities according to SOPs and regulatory guidelines.

General Responsibilities:

  • Maintain a thorough understanding of the adverse event profiles of assigned drugs, regulatory obligations, and clinical studies.
  • Prepare for and participate in audits and inspections, ensuring readiness and compliance.
  • Serve as the primary client contact, fostering collaboration to deliver high-quality work.
  • 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.
  • Ability to work collaboratively in a team-oriented environment with a client-focused approach.
  • Strong IT skills, including proficiency in MS Office and familiarity with web-based applications.

Knowledge and Experience:

  • Relevant experience in Regulatory, Pharmacovigilance, or a related field is desirable.
  • Good knowledge of medical terminologies.

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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