Company: Thermo Fisher Scientific
Division: PPD Clinical Research Services
Location: Bangalore, Karnataka, India (Fully Remote)
Job Type: Full-Time
Industry: Clinical Research | Pharmacovigilance | CRO
Experience Required: Minimum 2+ years in safety reporting, pharmacovigilance, or clinical research operations
Role Overview
A leading global Contract Research Organization (CRO) is seeking a detail-driven Safety Reporting Specialist to support global pharmacovigilance and clinical safety operations. This fully remote position based in Bangalore offers the opportunity to contribute to regulatory-compliant safety reporting across international clinical trials.
The selected candidate will be responsible for the preparation, submission, and monitoring of safety reports in accordance with global regulatory requirements and country-specific legislation. This role requires strong knowledge of medical terminology, global safety reporting guidelines, and regulatory timelines.
Key Responsibilities
Receive, process, and submit safety reports to regulatory authorities, ethics committees, and relevant stakeholders.
Ensure compliance with global pharmacovigilance regulations and reporting timelines.
Monitor reporting metrics and regulatory deadlines to maintain full compliance.
Lead large-scale safety reporting projects, ensuring adherence to agreed processes and submission timelines.
Collaborate with cross-functional departments to coordinate safety reporting activities.
Contribute to the development and refinement of departmental SOPs and procedural documentation.
Provide mentorship and guidance to junior team members and new hires.
Generate safety metrics and contribute to financial and project tracking activities.
Represent the safety reporting function as a primary contact for assigned projects.
Business & Stakeholder Engagement
Act as a key departmental representative in cross-functional project meetings.
Coordinate with internal teams and external stakeholders on critical safety matters.
Engage with senior personnel across functional areas to ensure alignment on compliance and reporting standards.
Required Qualifications
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
Equivalent vocational or academic qualifications may be considered.
Experience:
Minimum 2+ years of relevant experience in safety reporting, pharmacovigilance, or clinical research within pharmaceutical or CRO environments.
Experience working with global safety reporting requirements preferred.
Core Competencies & Skills
Strong knowledge of global safety reporting regulations and procedural documentation.
Excellent understanding of medical terminology.
Proficiency in Microsoft Office and familiarity with safety databases.
Strong analytical thinking, problem-solving, and decision-making skills.
Excellent time management and multitasking abilities.
High attention to detail with a compliance-focused mindset.
Ability to influence and collaborate across functional levels.
Strong negotiation and communication skills.
Ability to mentor junior colleagues in safety reporting processes.
Work Schedule & Environment
Standard Monday to Friday schedule
Fully Remote role (India-based)
Office-based virtual working environment
Accessibility & Equal Opportunity
The organization is committed to providing reasonable accommodations to individuals with disabilities throughout the recruitment and employment lifecycle.
As an Equal Opportunity Employer, all qualified applicants will receive consideration for employment without discrimination based on any legally protected characteristic.
About the Organization
Thermo Fisher Scientific is a global leader in serving science, with annual revenues exceeding $40 billion. Through its clinical research division, PPD, the company supports pharmaceutical and biotechnology organizations in accelerating drug development and ensuring patient safety worldwide. Its global teams deliver scientific, regulatory, and operational excellence across the clinical trial lifecycle.
Why Apply via ThePharmaDaily.com?
Access verified global pharmaceutical and CRO job opportunities
Discover remote pharmacovigilance and safety reporting roles
Advance your career in clinical research and regulatory compliance
If you are a safety reporting professional with experience in global pharmacovigilance operations and regulatory submissions, apply now to contribute to high-impact clinical research programs worldwide.
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