Safety Writer II | Thermo Fisher Scientific | Remote, India
Location: Remote, India
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Department: Clinical Research / Pharmacovigilance
Employment Type: Full-Time
Work Model: Fully Remote
Experience Required: Minimum 5 Years
Education Required: Bachelor’s Degree or Higher in Life Sciences, Pharmacy, Medicine, or Related Scientific Field
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in scientific research and healthcare innovation. Through its PPD clinical research services portfolio, the organization supports pharmaceutical, biotechnology, and healthcare companies in accelerating drug development and delivering safe and effective therapies to patients worldwide.
The clinical research division brings together scientific expertise, operational excellence, and regulatory knowledge to support clinical trials and pharmacovigilance programs. Over the past five years, the organization has supported the top 50 pharmaceutical companies and more than 750 biotechnology firms across over 2,700 clinical trials in more than 100 countries.
Job Overview
Thermo Fisher Scientific is seeking a Safety Writer II to support pharmacovigilance and clinical safety documentation within a global clinical research environment. This role involves planning, coordinating, and delivering safety writing services related to clinical trials and marketed pharmaceutical products.
The Safety Writer II will perform safety data review, authoring, and quality control activities while collaborating with project teams, clients, and regulatory stakeholders. The position requires strong medical writing expertise, regulatory knowledge, and the ability to manage multiple safety documentation projects within strict regulatory timelines.
Key Responsibilities
Safety Writing and Documentation
Prepare, review, and manage safety writing deliverables for clinical trial and marketed product safety reporting.
Author and review safety documents such as line listing reports and Periodic Adverse Drug Experience Reports (PA(D)ERs).
Develop moderate complexity safety reports including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Development Risk Management Plans (dRMPs).
Support senior team members in the preparation of higher complexity documents including Risk Management Plans (RMPs), regulatory submission content, and responses to regulatory authority assessment reports.
Data Analysis and Quality Review
Perform comprehensive safety data review and ensure accuracy, consistency, and regulatory compliance of safety reports.
Conduct quality control checks on pharmacovigilance documentation prior to submission.
Interpret clinical and safety data to support accurate safety reporting.
Project Coordination and Management
Act as the primary point of contact for assigned safety writing projects and deliverables.
Coordinate safety writing activities across cross-functional teams including pharmacovigilance, clinical operations, and regulatory affairs.
Lead project meetings such as kickoff discussions, data collection meetings, and status updates.
Collaboration and Stakeholder Communication
Work closely with internal project teams, client representatives, and external vendors.
Support client interactions, audits, and regulatory inspections when required.
Ensure effective communication and documentation management throughout the project lifecycle.
Process Improvement and Regulatory Awareness
Monitor updates in pharmacovigilance regulations, industry guidelines, and reporting requirements.
Participate in departmental initiatives and contribute to improvements in safety writing processes and procedures.
Assist in the development of procedural documentation and provide mentorship to junior staff members.
Required Skills and Competencies
Strong expertise in medical and scientific writing within pharmacovigilance and clinical safety environments.
Comprehensive understanding of ICH guidelines and global safety reporting standards for clinical trials and marketed products.
Excellent analytical skills with the ability to interpret complex clinical safety data.
Strong attention to detail and ability to maintain high quality documentation standards.
Ability to manage multiple projects simultaneously and meet strict deadlines.
Strong written and verbal communication skills in English.
Proficiency in Microsoft Office tools including Word, Excel, and Outlook.
Experience working with multiple clinical and pharmacovigilance systems and databases.
Strong problem-solving abilities and critical thinking skills.
Education Requirements
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related scientific discipline.
Experience Requirements
Minimum 5 years of experience in pharmacovigilance safety writing or medical writing within a pharmaceutical company, CRO, or clinical research organization.
Candidates should have 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) or Periodic Benefit Risk Evaluation Reports (PBRERs)
Periodic Adverse Drug Experience Reports (PA(D)ERs)
Risk Management Plans (RMPs)
Experience with global regulatory requirements related to clinical trial safety reporting and post-marketing pharmacovigilance is required.
Work Environment and Conditions
This is a fully remote position with standard office working hours. Work involves regular interaction with global project teams and clients. The role may require occasional extended working hours to meet project deadlines and limited domestic or international travel when necessary.
Why Join Thermo Fisher Scientific
Joining Thermo Fisher Scientific means becoming part of a global organization committed to advancing healthcare innovation and scientific discovery. Employees work in a collaborative environment where scientific expertise and professional development are highly valued.
The company provides opportunities to contribute to critical clinical research projects that help bring life-saving medicines and therapies to patients around the world.
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