Senior Medical Writer – Signal Management | Remote (India)
Job Summary:
Parexel is seeking a highly skilled Senior Medical Writer (SMW) to lead signal detection and management processes, safety evaluations, and regulatory documentation. This remote opportunity in India is perfect for professionals with strong expertise in pharmacovigilance, safety risk management, and regulatory writing. As part of the global safety team, you will influence early and late-stage drug development by contributing to critical benefit-risk assessments, new drug applications, and post-market safety surveillance activities.
Key Responsibilities:
Author signal management reports including Validations, SERs, and Health Authority (HA) requests.
Conduct signal detection reviews and analyses from diverse sources such as regulatory databases, literature, and client data.
Oversee end-to-end signal management processes, including tracking, assessment, and leading review meetings.
Collaborate closely with the Global Safety Officer (GSO) and safety team on evaluation activities.
Maintain deep knowledge of assigned drug safety profiles, labeling documents, SOPs, and global pharmacovigilance regulations.
Ensure compliance with global regulatory reporting requirements and internal safety processes.
Support clinical studies through narrative preparation and safety documentation.
Deliver training to new team members and contribute to continuous learning initiatives.
Required Skills & Qualifications:
University degree in Life Sciences/Health/Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.).
Advanced degree (Medicine, Dentistry, Physiotherapy, Nursing) preferred.
Relevant pharmacovigilance or regulatory experience highly desirable.
Strong knowledge of medical terminology and clinical development processes.
Excellent analytical, problem-solving, and communication skills.
Proficient in MS Office Suite (Word, Excel, PowerPoint) and web-based applications.
Ability to manage multiple tasks, prioritize workload, and ensure quality documentation.
Strong teamwork, negotiation, and client relationship-building capabilities.
Perks & Benefits:
Flexible remote work from anywhere in India.
Opportunity to influence global drug safety processes.
Collaborative, inclusive, and supportive work culture.
Access to continuous professional development programs.
Involvement in impactful clinical and post-market safety activities.
Company Description:
Parexel is a leading Clinical Research Organization (CRO) known for delivering world-class solutions in drug development, regulatory services, and pharmacovigilance. With a commitment to patient safety, scientific innovation, and healthcare advancement, Parexel empowers its global teams to make a difference in clinical research and life sciences.
Work Mode:
Remote (India)
Call to Action:
Ready to take your medical writing and pharmacovigilance career to the next level? Apply now to join Parexel’s expert global safety team and contribute to life-saving drug development.
Note:
The job description did not specify a salary range. You may add this information if provided later.
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