Medical Writer I, Patient Safety

Roles & Responsibilities
Safety Medical Writing & Aggregate Reporting
• Lead preparation of scheduled and ad-hoc aggregate safety reports such as PSUR, PBRER, DSUR, PADER, SASR, ARBE, and safety statements
• Independently manage simple reports and support medium-complexity reports under supervision
• Compile, analyze, and present safety data following regulatory templates and guidance
• Incorporate team review feedback and perform quality checks for consistency and data integrity
• Coordinate submission of safety documents to global regulatory authorities
• Prepare supporting documentation including labeling comparison documents, INN checks, and appendices
• Ensure timely delivery of high-quality regulatory safety documents

Safety Analysis & Signal Management
• Perform signal detection activities using safety databases, literature, clinical data, and regulatory sources
• Conduct quantitative and qualitative safety data analyses to identify potential signals
• Maintain and update signal tracking logs with minimal supervision
• Support safety evaluation activities for products with established safety profiles
• Prepare and contribute to Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs)
• Conduct literature searches and summarize findings for safety evaluations and epidemiology reports
• Identify and resolve discrepancies in safety data listings and source documents

Risk Management
• Assist in preparation and maintenance of Risk Management Plans (RMPs)
• Ensure accuracy, completeness, and consistency of risk-related documentation
• Support updates to risk minimization measures and safety communications

General Scientific & Operational Support
• Maintain working knowledge of assigned product safety profiles and therapeutic areas
• Apply proficiency in medical terminology and pharmacovigilance coding dictionaries (MedDRA, WHO-DD)
• Deliver high-quality outputs through detailed self-review and structured quality checks
• Contribute to safety discussions with evidence-based insights
• Communicate proactively regarding task progress, timelines, and challenges
• Prioritize multiple deliverables and consistently meet deadlines
• Maintain audit-ready documentation and ensure proper archiving
• Support inspection readiness and compliance activities

Client Engagement & Collaboration
• Manage routine client communications and respond to queries independently
• Escalate complex issues appropriately
• Provide proactive status updates and manage document review cycles
• Adapt to client-specific templates and regulatory requirements
• Collaborate cross-functionally in global team environments

Quality Control & Compliance
• Ensure deliverables meet global pharmacovigilance regulatory requirements
• Perform quality control checks and support oversight of junior team members
• Monitor KPIs and SLAs to ensure project timelines are met
• Participate in audit and compliance readiness activities
• Contribute to continuous process improvement initiatives

Learning & Innovation
• Complete advanced training programs and support team capability development
• Utilize safety databases, writing tools, and MS Office applications effectively
• Adapt to new technologies and support automation or process improvements

Qualification
• Bachelor’s or Master’s degree in Life Sciences / Health / Biomedical Sciences
• Preferred fields: Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, Physiotherapy or related discipline
• Master's of Pharmacy, Doctor of Pharmacy

Experience
• Prior experience in pharmacovigilance or drug safety preferred
• Understanding of global pharmacovigilance regulations and safety concepts
• Clinical or hospital-based exposure advantageous

Skills
• Strong analytical thinking and problem-solving ability
• Scientific writing expertise with regulatory compliance focus
• Proficiency in MS Office and medical writing tools
• Familiarity with pharmacovigilance databases and coding dictionaries (MedDRA, WHO-DD)
• Excellent organizational and time management skills
• Strong collaboration and interpersonal communication skills
• Ability to manage multiple projects and meet strict deadlines
• Adaptability and continuous learning mindset

About the Organization
Parexel is a leading global clinical research organization (CRO) that provides comprehensive drug development and regulatory consulting services to the pharmaceutical, biotechnology, and medical device industries. With a strong focus on patient safety, innovation, and regulatory excellence, Parexel offers a collaborative and growth-oriented environment for professionals in pharmacovigilance and medical writing.