Senior Safety Reporting Specialist
Job ID: R-01336116
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote
Location: India (Remote)
Work Schedule: Standard (Monday to Friday)
Work Environment: Office / Remote
About the Organization
Thermo Fisher Scientific’s Clinical Research Services team is at the forefront of advancing life-saving therapies from development to market. As part of the PPD® clinical research portfolio within a leading global Contract Research Organization (CRO), the team delivers high-quality scientific, operational, and regulatory expertise to address some of the world’s most complex healthcare challenges.
Role Overview
Thermo Fisher Scientific is seeking an experienced Senior Safety Reporting Specialist to support global pharmacovigilance and safety reporting operations. This role is responsible for the end-to-end management of expedited and periodic safety reports, ensuring compliance with global regulatory requirements and timelines. The position also provides leadership on projects, supports procedural development, and mentors team members, contributing to operational excellence and regulatory readiness across safety programs.
Experience Required
Minimum 3+ years of professional experience in safety reporting, pharmacovigilance, or clinical research operations
Demonstrated experience managing expedited and periodic safety reports in a regulated environment
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline
Equivalent combination of education, training, and directly relevant experience may be considered
Key Responsibilities
Receive, prepare, submit, and track expedited and periodic safety reports to regulatory authorities and other stakeholders
Ensure all safety reports comply with global regulatory timelines, country-specific legislation, and internal procedures
Lead large-scale safety reporting projects and programs, ensuring consistent delivery and regulatory compliance
Proactively identify quality or timeline risks and implement effective mitigation strategies
Serve as a primary point of contact for safety reporting activities on assigned projects
Collaborate with cross-functional teams to support safety reporting deliverables and process alignment
Contribute to the development, review, and updating of departmental and program-level procedural documents
Provide guidance, mentoring, and technical support to junior team members and new starters
Participate in regulatory intelligence activities and continuous improvement initiatives
Prepare metrics, performance reports, and support limited financial or project tracking activities
Required Knowledge, Skills, and Competencies
Strong knowledge of medical terminology and pharmacovigilance concepts
In-depth understanding of global safety reporting regulations and procedural requirements
Proficiency in Microsoft Office applications and working knowledge of safety databases
Excellent time management and multitasking abilities in a deadline-driven environment
High attention to detail with strong quality and compliance focus
Strong critical thinking, analytical, and problem-solving skills
Ability to influence and communicate effectively across all organizational levels
Demonstrated initiative with effective persuasion and negotiation skills
Ability to work collaboratively within cross-functional and global teams
Proven capability to coach and support less experienced colleagues
Professional Level
This position represents a fully qualified, career-level role requiring independent judgment, leadership, and the ability to resolve complex safety reporting challenges creatively and effectively.
Why Join Thermo Fisher Scientific
Opportunity to contribute to global drug safety and patient protection
Fully remote role with exposure to international clinical research programs
Collaborative, quality-driven environment within a leading global CRO
Continuous learning, professional development, and career progression opportunities
Equal Employment Opportunity
Thermo Fisher Scientific is an equal opportunity employer and is committed to building a diverse and inclusive workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, veteran status, or any other protected characteristic. Reasonable accommodations are available throughout the recruitment process upon request.
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