Medical Writer I / Medical Writer II Job at Parexel
A rare chance has emerged through this Parexel Medical Writer Job for aspiring Medical Writers in India. This opportunity invites qualified candidates to contribute to critical pharmacovigilance and safety activities that advance new treatments for patients. Positions are available in Hyderabad, Bengaluru, Mohali, and remote options.
About the Company
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, Parexel partners with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. The organization works with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies.
Parexel Medical Writer Job Details
- Locations: India – Hyderabad, India – Bengaluru, India – Mohali, India – Mohali – Remote, India – Hyderabad – Remote
- Posted on: 19 October 2023
- Job Requisition ID: R0000046349
About the Role
Parexel is seeking a Medical Writer I or II, Patient Safety to join their team in a hybrid / on-site/remote: capacity. In this Parexel Medical Writer Job, the successful candidate will support critical pharmacovigilance and safety activities that advance new treatments for patients and ensure regulatory compliance. This position plays a key role in developing regulatory safety documents, managing safety signals, and maintaining the highest standards of scientific accuracy and compliance.
Key Responsibilities
- Prepare, compile, and lead the 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.
Eligibility Criteria
- 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 a 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.
Medical Writing Role: Required Skills
- 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 an 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).
How to Apply
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
This opportunity at Parexel offers a chance to contribute to meaningful advancements in patient safety and regulatory compliance. Qualified candidates are encouraged to apply before the deadline to be part of a team dedicated to improving global health.
