Medical Writer-II, Patient Safety

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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, to the preparation and compilation of scheduled and unscheduled aggregate safety reports including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk- Benefit Evaluation (ARBE) report Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO), and specialized safety documents in accordance with regulatory requirements and client conventions.
• Responsible for independently leading medium complexity reports and supporting the development of complex reports in collaboration with senior team members.
• Reviews and finalizes safety documents for accuracy, compliance, and consistency, incorporating feedback and ensuring data integrity.
• Coordinates the submission process for safety documents to regulatory authorities across multiple regions

• Develop and refine supporting documentation including comprehensive comparison documents between local and global labeling.

Safety Analysis & Signal Management:

• Leads signal detection activities across multiple data sources, designing appropriate methodologies for specific product types
• Performs advanced data analysis to identify complex safety trends and patterns.
• Independently manages end-to-end signal tracking activities and develops improved tracking mechanisms
• Supports clinical safety activities for complex molecules, contributing to strategy discussions, data interpretation, and cross-functional alignment.
• Prepares detailed signal assessment documents (e.g., DSRs, SERs), providing support for complex reports and independently leading the development of simpler reports.
• Conducts literature searches and systematic reviews, critically appraising and summarizing findings on incidence, prevalence, and risk factors for inclusion in PSRs, drug safety reports, and RMPs.
• Identifies complex data discrepancies and implements systematic approaches to resolve

Risk Management Plan:

• Supports the development and updates of Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs) for various products, ensuring alignment with safety data and regulatory requirements.
• Collaborates with cross-functional teams to support accurate and compliant RMP development and assists in RMS (reference member state) in line with client standards, regulatory expectations, and internal procedures.

General Scientific Support:

• Demonstrates deep knowledge of safety profiles across multiple products and therapeutic areas.
• Applies expert-level understanding of medical terminology and coding systems (e.g., MedDRA, WHO-DD).
• Ensures high-quality deliverables through rigorous review and strategic feedback.
• Provides substantive contributions to safety strategy discussions based on scientific knowledge
• Effectively manages multiple high-complexity projects with overlapping deadlines, ensuring timely delivery and alignment with strategic objectives.
• Actively contributes to matrix team meetings, effectively representing medical writing perspectives and aligning with broader project goals.
• Develops and maintains audit-ready documentation systems to support inspection readiness and regulatory compliance.

Client Engagement & Communication

• Serves as the primary client liaison for assigned projects, independently resolving issues and ensuring alignment with client expectations.
• Leads routine and complex client discussions, providing strategic updates, anticipating challenges, and proposing effective solutions.
• Manages multi-stakeholder document review cycles and fosters cross-functional collaboration to drive project success.
• Demonstrates cultural competence in global communications, enhancing client engagement and project outcomes.

Quality Control & Compliance Management

• Provides guidance on regulatory requirements and ensures compliance across deliverables, reviews work of junior team members, identifies quality trends and recommends process improvements
• Monitors KPIs and SLAs for assigned deliverables, contributing significantly to their successful achievement.
• Participates effectively in audits and inspections, addressing findings comprehensively

Training & Team Development

• Supports onboarding and development of junior team members by mentoring technical and soft skills, providing constructive feedback, and delegating tasks to ensure balanced workload and quality deliverables.
• Contributes to team efficiency by delivering targeted training on safety writing topics and actively participating in departmental knowledge-sharing initiatives.

Innovation & Technology

• Supports the evaluation/adoption of new technologies and contributes to process improvement initiatives to enhance efficiency and writing quality.
• Shares best practices across teams to drive continuous improvement.

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 Solid 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.