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Senior Safety Reporting Specialist

Thermo Fisher Scientific
Thermo Fisher Scientific
3+ years
preferred by company
10 Jan. 9, 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 ID: R-01336116
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote

About the Role

Thermo Fisher Scientific is seeking an experienced Senior Safety Reporting Specialist to join our global Clinical Research and Pharmacovigilance (PV) team. This role is ideal for professionals with 3+ years of pharmacovigilance or safety reporting experience, who are looking to advance their career in a leading global contract research organization (CRO).

As a Senior Safety Reporting Specialist, you will manage the receipt, preparation, submission, and tracking of expedited and periodic safety reports across multiple projects. You will ensure regulatory compliance, data quality, and timely delivery while providing mentorship to junior team members and supporting process improvements.

Key Responsibilities

  • Receive, prepare, and submit safety reports in accordance with global regulatory timelines and local country requirements.

  • Lead complex projects to ensure all safety reports meet regulatory and client-specific standards.

  • Collaborate with cross-functional teams to develop, update, and maintain safety reporting procedures.

  • Provide guidance, mentorship, and training to junior staff, supporting professional development within the team.

  • Monitor compliance, identify quality or timeline issues, and proactively implement corrective actions.

  • Produce metrics, reports, and contribute to financial and project tracking as needed.

  • Act as a primary contact for internal and external stakeholders on significant safety reporting matters.

  • Contribute to regulatory intelligence activities and continuous improvement initiatives in safety reporting.

Education & Experience Requirements

  • Bachelor’s degree or equivalent in Life Sciences, Pharmacy, or related field.

  • Minimum 3+ years’ experience in pharmacovigilance, drug safety, or clinical research, preferably within a global CRO environment.

  • Experience with regulatory reporting and familiarity with global safety requirements.

  • Knowledge of procedural documentation, Microsoft Office, and database functionality.

Skills & Competencies

  • Strong knowledge of medical terminology and clinical trial processes.

  • Ability to manage multiple priorities and meet deadlines in a dynamic environment.

  • Excellent attention to detail and critical thinking skills.

  • Strong communication, interpersonal, and influencing skills across all levels of the organization.

  • Ability to work independently and collaboratively in a team-oriented environment.

  • Demonstrated initiative, problem-solving, and decision-making capabilities.

  • Ability to support and guide junior colleagues in complex pharmacovigilance tasks.

Why Join Thermo Fisher Scientific

  • Global exposure: Work on safety reporting for multinational clinical trials across regions.

  • Career growth: Gain expertise in pharmacovigilance, regulatory compliance, and project leadership.

  • Learning & development: Access tailored learning pathways, mentorship, and professional growth opportunities.

  • Impactful work: Contribute to life-changing therapies and patient safety on a global scale.

Thermo Fisher Scientific is a world leader in serving science, committed to enabling clients to make the world healthier, cleaner, and safer. Join a global team of 90,000+ colleagues, where your expertise in pharmacovigilance and safety reporting will make a measurable difference.

Thermo Fisher Scientific is an Equal Employment Opportunity Employer.