Safety Writer II
Location: Remote, India
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Job Type: Full-Time
Job Category: Pharmacovigilance / Drug Safety / Medical Writing
Work Mode: Fully Remote
Job ID: R-01342267
Experience Required: Minimum 5 Years
Job Overview
Thermo Fisher Scientific is seeking an experienced Safety Writer II to join its Clinical Research Services team in India. This remote role focuses on delivering high-quality pharmacovigilance and safety writing deliverables that support global clinical trials and marketed pharmaceutical products.
As part of the PPD clinical research portfolio, the Safety Writer II will contribute to safety reporting activities across clinical development programs and post-marketing surveillance. The role involves data analysis, regulatory safety documentation, and collaboration with cross-functional teams to ensure compliance with global pharmacovigilance standards.
The position offers an opportunity to work on international clinical research projects that support pharmaceutical and biotechnology companies in bringing safe and effective treatments to market.
Key Responsibilities
Safety Writing and Regulatory Documentation
Author, review, and manage safety documents for clinical trials and marketed products in accordance with global pharmacovigilance regulations.
Prepare and deliver safety writing reports of varying complexity including:
Periodic Adverse Drug Experience Reports (PA(D)ERs)
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs) / Periodic Benefit Risk Evaluation Reports (PBRERs)
Development Risk Management Plans (dRMPs)
Support preparation of higher complexity regulatory safety documents such as Risk Management Plans (RMPs), marketing authorization dossier safety sections, and regulatory authority responses.
Data Analysis and Quality Review
Perform safety data review, analysis, and interpretation for regulatory safety reports.
Conduct quality control checks to ensure accuracy, completeness, and regulatory compliance of safety documentation.
Maintain strict adherence to timelines and project deliverables in a regulated pharmacovigilance environment.
Project Coordination
Manage assigned safety writing deliverables and act as the primary point of contact for project stakeholders.
Coordinate with pharmacovigilance teams, clinical research professionals, clients, and external vendors.
Lead project kickoff meetings and manage communication for safety writing projects.
Track deliverables, budgets, and project metrics to ensure successful project execution.
Regulatory Compliance and Process Improvement
Ensure all documentation complies with global regulatory guidelines including ICH and regional pharmacovigilance standards.
Monitor updates in regulatory requirements and pharmacovigilance practices.
Contribute to departmental initiatives and assist in developing procedural documentation.
Team Support and Mentoring
Provide guidance and mentorship to junior safety writers and team members when required.
Support collaborative teamwork across cross-functional clinical research teams.
Required Qualifications
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
Experience Required
Minimum 5 years of experience in pharmacovigilance safety writing or regulatory medical writing.
Proven experience authoring and reviewing at least two or more of the following safety documents:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs) / PBRERs
Periodic Adverse Drug Experience Reports (PA(D)ERs)
Risk Management Plans (RMPs)
Key Skills
Pharmacovigilance and aggregate safety reporting
Regulatory medical writing for clinical trials and post-marketing products
Strong analytical and scientific writing skills
Data interpretation and safety signal evaluation
Project management and deadline management
Knowledge of ICH guidelines and global regulatory safety reporting requirements
Proficiency in Microsoft Office tools including Word, Excel, and Outlook
Strong communication and stakeholder collaboration skills
Work Environment
Fully remote work arrangement within India.
Standard work schedule of approximately 40 hours per week.
Occasional extended work hours depending on project timelines.
Limited domestic or international travel may be required.
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in scientific services and clinical research solutions. Through its PPD clinical research division, the company supports pharmaceutical and biotechnology organizations in developing innovative therapies and advancing global healthcare.
With extensive experience supporting thousands of clinical trials across more than 100 countries, Thermo Fisher Scientific collaborates with leading pharmaceutical companies and biotech organizations to accelerate drug development while maintaining the highest standards of patient safety and regulatory compliance.
Professionals joining the organization become part of a global team dedicated to advancing science and improving patient outcomes worldwide.
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