Job Summary
Join Parexel, a global leader in clinical research, as an Associate Manager – Safety Medical Writing. This role offers the opportunity to lead pharmacovigilance document development, aggregate safety report writing, CSR narratives, and signal detection activities. Ideal for experienced professionals in drug safety and medical writing, this position combines scientific expertise, client liaison, team leadership, and project management to deliver top-quality safety documents that comply with regulatory standards.
Key Responsibilities
Manage and mentor Safety Services (SS) staff in pharmacovigilance and medical writing.
Oversee the preparation of aggregate reports, CSR narratives, and safety documents.
Supervise adherence to regulatory guidelines (ICH, GVP, FDA, EMA) and internal SOPs.
Lead client communication, proposal development, and project planning.
Monitor project timelines, team performance, and billable utilization.
Support signal detection and management including signal assessment and tracking.
Provide training, process improvements, and audit readiness for the Safety Services team.
Ensure quality control and timely delivery of safety reports and regulatory documents.
Required Skills & Qualifications
Degree in Life Sciences, Medicine, Pharmacy, Biochemistry, Biotechnology, or related fields.
Strong background in pharmacovigilance, aggregate safety reporting, and clinical document authoring.
Proven project management and client-facing experience in a CRO or pharma environment.
Excellent interpersonal, verbal, and written communication skills.
Leadership qualities with experience in team management and mentorship.
Proficiency with MS Office, document management systems, and collaborative platforms like SharePoint.
Ability to handle confidential information and manage workload efficiently.
Business development awareness and ability to support proposal preparation.
Willingness to travel as required.
Fluency in written and spoken English.
Perks & Benefits
Remote work flexibility (Remote/Hybrid options available)
Comprehensive training programs and continuous learning opportunities
Leadership and mentorship growth paths
International career exposure in a top global CRO
Competitive salary and performance-based incentives
Access to cutting-edge pharmacovigilance projects and technologies
Company Description
Parexel is a globally renowned Clinical Research Organization (CRO) specializing in drug development and regulatory services for the pharmaceutical and healthcare sectors. With a strong commitment to innovation, compliance, and quality, Parexel empowers life sciences companies to accelerate breakthroughs that improve patient outcomes worldwide.
Work Mode
Remote (India-based) | Options for Hybrid in Bengaluru, Hyderabad, or SAS Nagar (Mohali)
Call to Action
Ready to take the next step in your pharmacovigilance writing career? Apply now to join Parexel’s global medical writing leadership team and make a real impact in drug safety and patient care.
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