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Medical Writer Ii

2+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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: Aggregate Report Specialist – Pharmacovigilance & Regulatory Affairs
Location: Remote (Global)

Job Purpose:
The Aggregate Report Specialist is responsible for managing the preparation, revision, and submission of various safety and regulatory reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs). This role ensures the quality, accuracy, and regulatory compliance of all aggregate reports and clinical study narratives, while also conducting signal detection and management. The specialist will work closely with cross-functional teams and clients to ensure timely and high-quality delivery of safety documents.

Key Responsibilities:

  1. Aggregate Reports Management:

    • Prepare, update, and merge safety reports such as PSURs, PBRERs, DSURs, RMPs, and other safety-related documents in accordance with client requirements and regulatory standards.
    • Conduct literature reviews with a focus on epidemiology, incidence, prevalence, and risk factors for inclusion in safety reports and RMPs.
    • Generate line listings and drug folders, ensuring data consistency and resolution of discrepancies.
    • Perform aggregate report compliance activities, ensuring internal consistency and regulatory adherence.
    • Distribute final reports to stakeholders and submit to health authorities according to agreed timelines.
  2. Clinical Study Report Narratives:

    • Coordinate with the Study Management Team (SMT) to develop narrative templates and ensure narrative quality.
    • Write clear and accurate clinical study narratives based on clinical and safety database outputs.
    • Perform quality checks on narratives, ensuring high standards and client expectations are met.
    • Provide narrative review support to the SMT and ensure narratives align with regulatory guidelines.
  3. Signal Detection and Management:

    • Perform signal detection analysis (qualitative and quantitative) from multiple sources such as regulatory databases and literature.
    • Lead the signal management process, including tracking, analysis, and presenting findings in collaboration with safety science teams.
    • Conduct signal detection activities according to standard operating procedures (SOPs) and regulatory guidelines.
  4. General Responsibilities:

    • Maintain up-to-date knowledge of adverse event safety profiles, client guidelines, and global regulatory reporting obligations.
    • Participate in audits, inspections, and ongoing training to ensure compliance with regulations and client expectations.
    • Mentor and train new recruits, ensuring effective team development and knowledge transfer.
    • Act as the primary client contact for assigned projects, ensuring clear communication and high-quality work.
    • Respond to client inquiries and ensure timely, high-quality deliverables.
    • Support process improvement initiatives to enhance the efficiency of the reporting and safety processes.

Skills and Experience:

  • Analytical & Problem-Solving: Ability to evaluate data, identify discrepancies, and resolve issues independently.
  • Interpersonal & Communication: Strong verbal and written communication skills with the ability to work collaboratively in a team environment.
  • Organizational & Prioritization: Ability to manage multiple tasks effectively and prioritize workload.
  • Client-Focused: Understanding client needs and ensuring high levels of client satisfaction.
  • Proficiency with IT & Tools: Expertise in MS Office (Word, Excel, PowerPoint) and familiarity with web-based applications.
  • Medical Writing: Ability to synthesize and write clear, accurate, and concise medical text, including clinical narratives and regulatory reports.

Education:

  • A university degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Biochemistry, Biotechnology, etc.) is required.
  • A degree in Medicine, Dentistry, Physiotherapy, or a related clinical field is advantageous.

Desired Experience:

  • Relevant experience in Regulatory Affairs, Pharmacovigilance, or related fields.
  • Familiarity with medical terminology and experience in preparing safety and clinical study reports.

#LI-REMOTE
This is a remote position, offering flexibility while contributing to high-quality pharmacovigilance and regulatory safety reports across global healthcare projects.