Medical Writer I, Patient Safety

key Accountabilities:

Note: The below statements describe the general nature and level of the work being performed and are
not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable.

Safety Medical Writing and Safety Analysis

Aggregate Safety Reports & Documentation: 

• Leads or contributes independently, with supervision, to the preparation and compilation of both scheduled and ad-hoc aggregate safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs) Development Safety Update Reports (DSURs) Periodic Adverse Drug Experience Reports (PADERs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report Safety statements, following established templates and guidance.
• Responsible for independently leading simple reports and supporting the development of medium complexity reports under guidance.
• Incorporates team review feedback into document drafts, ensuring all relevant input is addressed and conducting quality reviews to verify consistency and data integrity across safety reports.
• Coordinates the submission process for safety documents to regulatory authorities across multiple regions.
• Generates supporting documentation including comparison documents between local and global labeling, INN checking, and appendices.

Safety Analysis & Signal Management: 

• Independently performs signal detection activities by collecting and analyzing data from various sources (databases, clinical, literature, regulatory websites) in accordance with applicable procedural documents.
• Performs both quantitative and qualitative analyses of safety data using established methodologies to identify potential safety signals.
• Manages signal tracking activities and maintains comprehensive signal logs with minimal supervision.
• Supports safety activities for simple molecules with established profiles, contributing to data interpretation and team discussions.
• Assists in preparing signal assessment documents, such as Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs), which summarize data from various sources.
• Conducts literature searches and reviews publications to summarize safety data for signal evaluation, PSRs, and epidemiology reports.
• Identifies and resolves data discrepancies in line listings and other safety data sources to ensure data integrity.

Risk Management Plan:

• Assists in preparing and updating Risk Management Plans (RMPs) and related documents, ensuring accuracy and compliance. 
• Collaborates with team members to maintain consistency i risk-related documents and communication.

 General Scientific Support: 

• Demonstrates good working knowledge of the safety profiles of assigned products and therapeutic areas.
• Demonstrates proficiency in medical terminology and pharmacovigilance coding dictionaries (MedDRA, WHO-DD)
• Delivers high-quality outputs through meticulous self-review and effective incorporation of feedback.
• Contributes meaningfully to team discussions on safety findings, offering substantive insights based on experience.
• Communicate proactively with team members to share updates on task progress, address challenges, and manage timelines effectively.
• Effectively prioritizes tasks and consistently meets deadlines. 
• Maintains audit-ready documentation and ensures proper archivingof source materials and communications. Supports inspection readiness activities as directed by supervisors.

Client Engagement & Collaborative Communication

• Manages client interactions effectively; handles routine queries independently while escalating complex issues; demonstrates cultural sensitivity with global stakeholders.
• Delivers proactive status updates; efficiently manages document cycles; adapts to client-specific requirements and templates.
• Collaborates seamlessly across functions while demonstrating cultural sensitivity with global stakeholders to deliver integrated, respectful client service.

Quality Control & Compliance Management

• Applies knowledge of global regulatory requirements to ensure timely, high-quality deliverables through robust quality control and oversight of junior team members.
• Monitors KPIs and SLAs to support successful project execution and participates in audit readiness activities, contributing to continuous improvement.

Learning and Development

• Completes advanced training and contributes to team efficiency through practical guidance and collaboration.

Innovation & Technology

• Effectively uses tools and systems, adapts to new technologies, and supports process improvements to enhance efficiency and maintain high-quality outputs.

Skills:

• Analytical thinking and problem-solving to interpret complex safety data and draw meaningful conclusions. 
• Scientific writing and communication expertise, with the ability to produce clear, accurate, and compliant documents. 
• Strong collaboration and interpersonal skills for effective teamwork across cross-functional, global teams and client interactions. 
• Excellent organizational and time management, with the ability to prioritize tasks, manage multiple projects, and meet deadlines. 
• Proficiency in medical writing tools and MS Office applications, with familiarity in pharmacovigilance databases and coding dictionaries (e.g., MedDRA, WHO-DD). 
• Adaptability and continuous learning mindset, with a proactive approach to new technologies and evolving processes. 

Knowledge and Experience:

• Prior experience in pharmacovigilance, or related fields is preferred. 
• Demonstrates good understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts. 

Education:

• Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc. Or equivalent combination of training and work experience. Clinical exposure in hospital-based environments is considered advantageous.