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Senior Safety Reporting Specialist

Thermo Fisher Scientific
Thermo Fisher Scientific
3+ years
preferred by company
10 Jan. 2, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Safety Reporting Specialist – Remote, India

Location: Remote, India
Job Type: Full-time
Category: Clinical Research / Pharmacovigilance
Experience Required: 3+ years
Job ID: R-01336116


Overview

Thermo Fisher Scientific, through its PPD® clinical research services, is a global leader in delivering innovative therapies and advancing patient health. We are seeking a Senior Safety Reporting Specialist to join our fully remote India-based team. In this role, you will manage safety reporting processes, ensuring timely and compliant submission of expedited and periodic safety reports across clinical research projects.

The ideal candidate will be a seasoned pharmacovigilance professional with strong regulatory knowledge, project management capabilities, and the ability to mentor junior team members. This is a critical role for supporting operational excellence and patient safety within a global CRO environment.


Key Responsibilities

  • Receive, prepare, submit, and track expedited and periodic safety reports according to regulatory timelines and country-specific legislation.

  • Lead large-scale safety reporting projects, ensuring compliance with global and local processes and deadlines.

  • Provide guidance and mentorship to junior team members, supporting their development and ensuring consistency in quality.

  • Collaborate with cross-functional departments to coordinate safety reporting tasks and attend relevant meetings.

  • Contribute to the development and improvement of program and departmental procedural documents.

  • Analyze metrics, support reporting requirements, and assist in financial and resource planning for assigned projects.

  • Proactively identify and resolve quality or timeline issues, escalating when necessary.

  • Share best practices and provide input to enhance department efficiency and compliance.


Qualifications

  • Bachelor’s degree in life sciences, pharmacy, or equivalent; advanced degree preferred.

  • 3+ years of experience in pharmacovigilance, safety reporting, or related clinical research roles.

  • Strong understanding of global safety reporting requirements, regulatory guidelines, and procedural documentation.

  • Proven experience in expedited and periodic report submissions within a CRO or pharmaceutical environment.


Skills & Competencies

  • Excellent knowledge of medical terminology and pharmacovigilance principles.

  • Proficient in Microsoft Office and safety databases; strong analytical and database skills.

  • Exceptional time management, multi-tasking, and attention to detail.

  • Ability to influence and collaborate effectively across all organizational levels.

  • Strong critical thinking, problem-solving, persuasion, and negotiation skills.

  • Experience mentoring or guiding lower-level colleagues in safety reporting activities.

  • Ability to work independently in a remote, fully distributed team environment.


Why Join Thermo Fisher Scientific

  • Fully remote role within India with flexible working arrangements.

  • Opportunity to work on global clinical research projects impacting patient safety and healthcare outcomes.

  • Access to professional development programs to enhance skills and career growth.

  • Collaborative and inclusive culture with a strong emphasis on operational excellence and innovation.

  • Competitive salary, benefits, and recognition programs supporting work-life balance and well-being.

Thermo Fisher Scientific is committed to fostering diverse, inclusive, and high-performing teams. Join our team and play a vital role in advancing patient safety, regulatory compliance, and clinical research excellence.