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Safety Writer Iii

Thermo Fisher Scientific
Thermo Fisher Scientific
6+ years
preferred by company
Remote
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Safety Writer III

Location: Remote, India
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Job Type: Full-Time
Work Mode: Fully Remote
Industry: Pharmacovigilance | Drug Safety | Clinical Research | Regulatory Writing | CRO
Department: Clinical Research Services / Pharmacovigilance Safety Writing
Job Reference ID: R-01343013
Work Schedule: Monday to Friday

Job Overview

Thermo Fisher Scientific is hiring a Safety Writer III for its PPD Clinical Research Services division in India. This is a senior-level fully remote opportunity for experienced professionals with expertise in pharmacovigilance safety writing, aggregate safety reporting, regulatory medical writing, drug safety documentation, risk management plans, and clinical research safety compliance.

The selected candidate will lead planning, authoring, project coordination, and quality review of complex global pharmacovigilance safety deliverables for clinical trial and marketed pharmaceutical products in a highly regulated CRO environment.

This role is ideal for professionals seeking senior career growth in drug safety writing, pharmacovigilance regulatory documentation, aggregate reporting, and global clinical research safety operations.

Job Responsibilities

Pharmacovigilance Safety Writing

Lead end-to-end safety writing activities for clinical trial and marketed product programs, including:

  • Safety data review
  • Regulatory safety document authoring
  • Quality review
  • Senior scientific review
  • Deliverable coordination
  • Project execution management

Ensure high-quality, compliant, and timeline-driven pharmacovigilance documentation.

Aggregate Safety Report Writing

Author, review, and manage a broad range of pharmacovigilance safety deliverables including:

Low Complexity Deliverables

  • Line Listing Reports
  • PA(D)ERs (Periodic Adverse Drug Experience Reports)

Medium Complexity Deliverables

  • DSURs (Development Safety Update Reports)
  • PSURs (Periodic Safety Update Reports)
  • PBRERs (Periodic Benefit-Risk Evaluation Reports)
  • Development Risk Management Plans (dRMPs)

High Complexity Deliverables

  • Risk Management Plans (RMPs)
  • Marketing Authorization dossier safety content
  • Regulatory authority response documents
  • Customized pharmacovigilance safety reports

Project Leadership & Coordination

  • Serve as the primary point of contact for assigned safety writing projects.
  • Lead:
    • Kick-off meetings
    • Client communications
    • Safety data requests
    • Internal coordination meetings
    • Deliverable planning
    • Timeline tracking
  • Ensure seamless execution across multiple stakeholders.

Client & Cross-Functional Collaboration

Collaborate with:

  • Pharmacovigilance project teams
  • Clinical research teams
  • PPD / Evidera teams
  • Client safety stakeholders
  • Third-party vendors
  • Regulatory partners

Support global safety deliverable execution in CRO and FSP environments.

Regulatory Compliance & Quality Management

Ensure compliance with:

  • Global pharmacovigilance regulations
  • Company SOPs
  • Contractual obligations
  • Client requirements
  • Quality standards
  • Regulatory submission expectations

Scientific Safety Support

  • Provide ad hoc scientific safety support as required.
  • Support specialized pharmacovigilance projects and custom safety documentation requests.

Regulatory Intelligence

  • Monitor pharmacovigilance regulations, regulatory updates, and industry best practices.
  • Maintain awareness of evolving global safety reporting expectations.

Mentorship & Subject Matter Expertise

  • Mentor junior and mid-level safety writers.
  • Act as subject matter expert (SME) in designated pharmacovigilance writing areas.
  • Support departmental knowledge sharing and process excellence initiatives.

Audits, Inspections & Metrics

  • Participate in:
    • Client audits
    • Regulatory inspections
    • Performance reviews
    • Budget discussions
    • Metrics review meetings

Support operational excellence in safety writing services.

Educational Qualification

Candidates must have:

  • Bachelor’s Degree in a scientific discipline

Preferred:

  • Master’s Degree
  • PhD
  • Pharmacy
  • Life Sciences
  • Biomedical Sciences
  • Medicine
  • Clinical Research backgrounds

Experience Requirements

  • Minimum 6+ years of hands-on pharmacovigilance safety writing experience
  • Mandatory experience authoring and quality reviewing:
    • DSURs
    • PBRERs / PSURs
    • PA(D)ERs
    • RMPs
  • Freshers are not eligible

Required Skills

  • Pharmacovigilance
  • Drug Safety Writing
  • Aggregate Safety Reporting
  • DSUR
  • PSUR
  • PBRER
  • PA(D)ER
  • Risk Management Plans (RMP)
  • Regulatory Medical Writing
  • Clinical Safety Documentation
  • Benefit-Risk Reporting
  • Safety Data Review
  • Marketing Authorization Documentation
  • CRO Pharmacovigilance
  • Client Communication
  • Quality Review
  • Regulatory Compliance
  • Project Management