Website Parexel ltd
Post Name: Medical Writer I / Medical Writer II
Key Responsibilities:
Prepare, compile, and lead development of scheduled and ad-hoc aggregate safety reports including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and other regulatory safety documents, ensuring accuracy and timely submission across multiple regions
Conduct independent signal detection activities by collecting and analyzing safety data from multiple sources including databases, clinical data, literature, and regulatory websites, applying both quantitative and qualitative methodologies to identify potential safety signals
Prepare comprehensive signal assessment documents such as Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs), synthesizing data from various sources and providing clear, evidence-based conclusions
Conduct systematic literature searches and reviews to summarize safety data, identify emerging safety trends, and support signal evaluation and epidemiology assessments
Manage signal tracking activities, maintain comprehensive signal logs, identify and resolve data discrepancies in safety data sources, and ensure data integrity across all deliverables
Assist in preparing and updating Risk Management Plans (RMPs) and related documents, ensuring alignment with safety data and regulatory requirements across therapeutic areas
Manage client interactions effectively, handle routine queries independently, escalate complex issues appropriately, and deliver proactive status updates while adapting to client-specific requirements
Maintain audit-ready documentation, ensure proper archiving of source materials, and support inspection readiness activities to ensure regulatory compliance
For Medical Writer II positions: Mentor junior team members on technical and soft skills, provide constructive feedback, lead complex client discussions, manage multi-stakeholder document review cycles, and contribute to process improvement initiatives
You’ll thrive in this role if you bring:
Strengths in analytical thinking, scientific writing, and problem-solving to interpret complex safety data and draw meaningful conclusions
Experience working in pharmacovigilance, healthcare, or a regulated environment with understanding of global regulatory requirements
The ability to collaborate across teams and communicate clearly with both internal stakeholders and external clients
A patient-focused mindset, strong attention to detail, and commitment to producing high-quality, compliant deliverables
Comfort working with medical writing tools, MS Office applications, and pharmacovigilance databases and coding dictionaries (MedDRA, WHO-DD)
Required Qualifications:
University degree in Life Sciences, Health, or Biomedical Sciences (such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy) or equivalent combination of training and work experience
2+ years of experience in pharmacovigilance, medical writing, or related field (Medical Writer I); 4+ years of experience (Medical Writer II)
Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts
Proficiency in medical writing tools and MS Office applications with familiarity in pharmacovigilance databases and coding dictionaries
Strong communication, organization, and problem-solving skills with excellent time management and ability to prioritize multiple concurrent projects
Preferred Qualifications:
Prior experience in pharmacovigilance or related safety assessment fields
Clinical exposure in hospital-based environments or direct clinical research experience
Expertise in specific therapeutic areas or product types
Familiarity with pharmacovigilance systems and regulatory submission processes across multiple regions.
