Safety Writer IV – Clinical Research (Fully Remote)
Location: Remote – India
Function: Clinical Research / Pharmacovigilance
Job Type: Full-Time
Company Overview
Thermo Fisher Scientific, through its PPD clinical research portfolio, is a leading global Contract Research Organization (CRO) delivering innovative clinical research and pharmacovigilance solutions. Supporting top pharmaceutical and biotechnology companies worldwide, the organization plays a critical role in advancing therapies across global markets.
Role Overview
The Safety Writer IV is a senior-level pharmacovigilance professional responsible for planning, authoring, reviewing, and project managing aggregate safety reports for clinical trial and marketed products. Operating within a highly regulated environment, this role ensures delivery of high-quality safety writing services aligned with global regulatory standards and strict timelines.
This opportunity is ideal for experienced pharmacovigilance and medical writing professionals seeking fully remote Safety Writer jobs in India within a global CRO environment.
Key Responsibilities
Aggregate Safety Report Authoring & Review
Lead data review, authoring, quality control, and senior review of aggregate safety reports across varying levels of complexity.
Prepare and manage low complexity reports such as PA(D)ERs and line listing reports.
Author moderate complexity documents including DSURs, PSURs, and PBRERs.
Develop high complexity deliverables such as Risk Management Plans (RMPs), marketing authorization dossier safety content, customized safety documents, and regulatory authority responses.
Serve as consultant and subject matter expert for high-impact safety writing projects.
Project Management & Leadership
Act as primary point of contact for assigned safety writing deliverables.
Lead project kick-off meetings, manage data requests, and coordinate communications with clients and internal stakeholders.
Participate in audits, inspections, and client meetings as required.
Oversee staff activities, mentor junior writers, and provide performance input where applicable.
Contribute to departmental initiatives and process improvements.
Regulatory & Compliance Oversight
Ensure all safety deliverables comply with ICH guidelines, US and global pharmacovigilance regulations, and company SOPs.
Monitor updates in regulatory publications and evolving safety reporting standards.
Support functional service provider (FSP) client engagements with full regulatory compliance.
Scientific & Technical Collaboration
Collaborate with cross-functional PV project teams, Evidera teams, clients, and third-party vendors.
Utilize multiple internal and client systems to manage safety documentation and reporting workflows.
Educational Qualifications
Bachelor’s Degree or higher in Life Sciences, Pharmacy, Medicine, or related scientific discipline.
Experience Required
Minimum 8+ years of experience in pharmacovigilance safety writing for innovative medicinal products.
Proven experience authoring and performing quality control review for the following aggregate reports:
DSURs
PBRERs / PSURs
PA(D)ERs
Risk Management Plans (RMPs)
Strong exposure to global regulatory environments including ICH and US safety reporting standards.
Knowledge, Skills & Competencies
Advanced expertise in aggregate safety reporting for clinical trials and marketed products.
Strong medical-scientific writing and data interpretation skills.
Excellent project management capabilities with experience handling multiple concurrent deliverables.
Deep understanding of global pharmacovigilance regulations and compliance frameworks.
Advanced proficiency in Microsoft Office (Word, Excel, Outlook) and regulatory documentation systems.
Strong leadership, mentoring, and communication skills.
Ability to work effectively in high-pressure, deadline-driven environments.
Working Environment
Fully remote role within India.
Standard 40-hour work schedule with occasional extended hours depending on project needs.
Interaction with global clients and cross-functional teams.
Occasional domestic or international travel may be required.
Why Join Thermo Fisher Scientific?
Contribute to global clinical research programs supporting leading pharmaceutical and biotech companies.
Work in a highly collaborative and innovation-driven CRO environment.
Opportunity to lead high-complexity safety writing projects at a global scale.
SEO & GEO Keywords: Safety Writer IV Remote India, Pharmacovigilance Safety Writer Jobs India, Aggregate Safety Report Writing Careers, DSUR PSUR RMP Jobs Remote, Clinical Research Safety Writing Jobs India, Thermo Fisher Scientific Safety Writer Careers.
This position is designed for senior pharmacovigilance professionals seeking remote Safety Writer IV roles in India with expertise in aggregate safety reporting, regulatory compliance, and global clinical research project leadership.
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Niš |Bohemia :
Prague |Chile :
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