Senior Safety Reporting Specialist – Pharmacovigilance
Job ID: R-01337635
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance / Drug Safety
Work Mode: Fully Remote
Location: India
Job Overview
A leading global Contract Research Organization (CRO) within the PPD® Clinical Research portfolio at Thermo Fisher Scientific is seeking a Senior Safety Reporting Specialist to support global pharmacovigilance and safety reporting activities. This role is critical in ensuring accurate, compliant, and timely submission of expedited and periodic safety reports in accordance with global regulatory requirements.
As a senior-level professional, you will lead safety reporting projects, provide subject-matter expertise, mentor junior team members, and contribute to process improvements, regulatory intelligence, and procedural development across safety operations.
Key Responsibilities
Receive, prepare, submit, and track expedited and periodic safety reports for assigned clinical research projects
Ensure full compliance with global regulatory timelines, country-specific legislation, and internal SOPs
Proactively identify quality, compliance, or timeline risks and escalate concerns to management with proposed solutions
Lead large-scale safety reporting projects, ensuring consistent adherence to agreed processes and regulatory expectations
Act as a primary safety reporting contact for assigned studies and cross-functional teams
Collaborate with internal stakeholders and external partners on safety-related activities and deliverables
Support the development, review, and updating of departmental SOPs, work instructions, and procedural documents
Contribute to regulatory intelligence activities related to global safety reporting requirements
Mentor, guide, and support junior safety reporting specialists and new team members
Generate safety metrics and support reporting dashboards and project tracking activities
Participate in meetings and provide expert input on safety reporting strategy and execution
Required Education & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline
Minimum 3+ years of relevant experience in pharmacovigilance or safety reporting (mandatory)
Demonstrated experience handling expedited and periodic safety reports in a global regulatory environment
Equivalent combinations of education, formal training, and directly related experience may be considered
Required Skills & Competencies
Strong knowledge of global safety reporting regulations and requirements
Excellent understanding of medical terminology and clinical safety data
Proficiency in Microsoft Office applications and strong understanding of safety databases and tracking systems
Thorough knowledge of safety-related SOPs, procedural documents, and compliance frameworks
Strong time management and multitasking abilities in a high-volume environment
Exceptional attention to detail with a focus on data accuracy and quality
Ability to influence and collaborate effectively across functional areas and organizational levels
Strong critical thinking, analytical, and problem-solving skills
Demonstrated initiative with the ability to lead, persuade, and negotiate when required
Proven ability to mentor and support junior colleagues in safety reporting activities
Strong communication skills and the ability to work effectively in a collaborative, global team setting
Why Join Thermo Fisher Scientific
Be part of a global CRO supporting life-changing clinical research programs
Fully remote role offering flexibility and work-life balance
Opportunity to lead complex, global safety reporting projects
Strong emphasis on professional growth, leadership development, and continuous learning
Work within a collaborative, quality-driven, and compliance-focused environment
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® Clinical Research Services, the organization delivers comprehensive clinical development solutions across more than 100 countries.
Thermo Fisher Scientific is an equal opportunity employer committed to diversity, equity, and inclusion.
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